MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Review of the manufacturing record and shipping inspection record of the involved product/lot# combination confirmed there was no indication of anomaly in them.A search of the complaint file found no similar report with the involved product code/lot# combination from other facilities.The actual sample and the concurrently used guidewire were received by ashitaka factory on december 23, 2021.Inspection of the actual sample was performed.Visual inspection confirmed that the actual sample had been broken apart.The proximal portion measured 1260 mm in length.The distal portion was 220 mm in length and stuck to the concurrently used guidewire.Magnifying inspection of the actual sample obtained the following findings.Distal portion: flaring of distal end.Tear in the distal end of the outer layer.Buckling of the catheter shaft from approximately 10 mm to 220 mm from the distal end.Fracture of the outer layer about 220 mm from the distal end.Fracture of the reinforcing coil and inner layer at approximately 230 mm from the distal end.The distal end of the distal portion had been flared but no fracture was observed on this area, therefore it was considered that there was no portion missing from the shaft.Proximal portion: fracture of the outer layer, the reinforcing coil, and the inner layer at the distal end of the proximal portion.Electron microscopic inspection of the distal portion confirmed the tear in the distal end of the outer layer and multiple abrasions on the outer layer surface.No scratches were observed on the proximal side of the tear and abrasions.From this, it was inferred that the distal end of the actual sample was exposed to a hard object and abraded, which resulted in the tear of the outer layer at the distal end.The concurrently used guidewire was separated from the distal portion of the actual sample, and then subjected to magnifying inspection.White foreign matter was found attached to its surface.The white foreign matter was subjected to component analysis by ft-ir and confirmed to be contrast media.From the investigation result 4 and 5, it was presumed that contrast media was adhering between the inner surface of the actual sample and the concurrently used guidewire surface due to some factors.The outer diameter and inner diameter of the actual sample were measured on the normal section and no dimensional anomaly was observed.The outer diameter of the concurrently used guidewire was confirmed 0.33 mm.As the maximum guidewire outer diameter applicable to the actual sample is specified as 0.016"(0.41 mm), it was confirmed that the concurrently used guidewire was compatible with the actual sample.Simulation testing was performed.A guidewire was inserted in a factory retained progreat sample and then the distal end of the progreat was trapped.Subsequently, for the release of the trapped state, the progreat was grasped at the proximal and subjected to pulling/pushing manipulation.As a result, the distal side of the progreat was buckled, and the outer layer, reinforcing coil, and the inner layer were fractured.These conditions were similar to those observed on the actual sample.Ashitaka factory is always continuing diligence in maintaining the product quality by performing extensive testing and inspections, for example, as follows.The catheter is always run through the production process with a core wire inserted in the lumen of the catheter shaft so that the patency of the lumen is assured.After the assembling process, 100% insertion inspection is performed with a core wire conforming to the maximum applicable guide wire being inserted throughout the entire length of the catheter.100% visual inspection is performed for any defective, including a kink or crush, before the packing process.Based on the investigation result, as one of the possibilities, this case was considered to be caused by the following mechanism.The distal end of the actual sample was trapped by some hard object when the actual sample was in the state of being combined with the concurrently used guidewire.In order to release the trap, the actual sample was grasped at the proximal shaft and repeatedly pushed and pulled.As a result, the actual sample was buckled and fractured.In addition, the fact that the contrast media had adhered to the inner surface of the actual sample and the outer surface of the concurrently used guidewire for some reason was thought to be one of the factors that promoted the trapped state.Ifu states: "if any resistance is felt, do not remove the micro catheter by force.Withdraw the catheter carefully together with the guiding catheter.Removing the catheter by force may result in the catheter breakage/separation, which may necessitate retrieval." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the physician used a.016 fathom wire with the microcatheter even after being advised by the terumo field clinical specialist that sometimes the jacket on that wire is bigger than.016 and can cause the wire to get stuck.The physician was just about where he wanted to be with the microcatheter however wanted a couple more centimeters so he removed the.016 fathom wire and inserted a.014 nitrex wire so he could remove the microcatheter and take off the touhy to gain the few centimeters he needed.When he did that, he noticed the tip of the microcatheter was damaged and could not be put back on the wire to reinsert.At that point he was given another progreat alpha 2.0 and they were able to complete the case without issue.The estimated blood loss was less than 250cc.The patient was in stable condition and the procedure outcome was successful.Additional information was received on-09-dec 2021: the procedure for the patient was a prostate artery embolization.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Review of the manufacturing record and shipping inspection record of the involved product/lot# combination confirmed there was no indication of anomaly in them.A search of the complaint file found no similar report with the involved product code/lot# combination from other facilities.The actual sample and the concurrently used guidewire were received by ashitaka factory on december 23, 2021.Inspection of the actual sample was performed.Visual inspection confirmed that the actual sample had been broken apart.The proximal portion measured 1260 mm in length.The distal portion was 220 mm in length and stuck to the concurrently used guidewire.Magnifying inspection of the actual sample obtained the following findings.Distal portion: flaring of distal end.Tear in the distal end of the outer layer.Buckling of the catheter shaft from approximately 10 mm to 220 mm from the distal end.Fracture of the outer layer about 220 mm from the distal end.Fracture of the reinforcing coil and inner layer at approximately 230 mm from the distal end.The distal end of the distal portion had been flared but no fracture was observed on this area, therefore it was considered that there was no portion missing from the shaft.Proximal portion: fracture of the outer layer, the reinforcing coil, and the inner layer at the distal end of the proximal portion.Electron microscopic inspection of the distal portion confirmed the tear in the distal end of the outer layer and multiple abrasions on the outer layer surface.No scratches were observed on the proximal side of the tear and abrasions.From this, it was inferred that the distal end of the actual sample was exposed to a hard object and abraded, which resulted in the tear of the outer layer at the distal end.The concurrently used guidewire was separated from the distal portion of the actual sample, and then subjected to magnifying inspection.White foreign matter was found attached to its surface.The white foreign matter was subjected to component analysis by ft-ir and confirmed to be contrast media.From the investigation result 4 and 5, it was presumed that contrast media was adhering between the inner surface of the actual sample and the concurrently used guidewire surface due to some factors.The outer diameter and inner diameter of the actual sample were measured on the normal section and no dimensional anomaly was observed.The outer diameter of the concurrently used guidewire was confirmed 0.33 mm.As the maximum guidewire outer diameter applicable to the actual sample is specified as 0.016"(0.41 mm), it was confirmed that the concurrently used guidewire was compatible with the actual sample.Simulation testing was performed.A guidewire was inserted in a factory retained progreat sample and then the distal end of the progreat was trapped.Subsequently, for the release of the trapped state, the progreat was grasped at the proximal and subjected to pulling/pushing manipulation.As a result, the distal side of the progreat was buckled, and the outer layer, reinforcing coil, and the inner layer were fractured.These conditions were similar to those observed on the actual sample.Ashitaka factory is always continuing diligence in maintaining the product quality by performing extensive testing and inspections, for example, as follows.The catheter is always run through the production process with a core wire inserted in the lumen of the catheter shaft so that the patency of the lumen is assured.After the assembling process, 100% insertion inspection is performed with a core wire conforming to the maximum applicable guide wire being inserted throughout the entire length of the catheter.100% visual inspection is performed for any defective, including a kink or crush, before the packing process.Based on the investigation result, as one of the possibilities, this case was considered to be caused by the following mechanism.The distal end of the actual sample was trapped by some hard object when the actual sample was in the state of being combined with the concurrently used guidewire.In order to release the trap, the actual sample was grasped at the proximal shaft and repeatedly pushed and pulled.As a result, the actual sample was buckled and fractured.In addition, the fact that the contrast media had adhered to the inner surface of the actual sample and the outer surface of the concurrently used guidewire for some reason was thought to be one of the factors that promoted the trapped state.Ifu states: "if any resistance is felt, do not remove the micro catheter by force.Withdraw the catheter carefully together with the guiding catheter.Removing the catheter by force may result in the catheter breakage/separation, which may necessitate retrieval." terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the physician used a.016 fathom wire with the microcatheter even after being advised by the terumo field clinical specialist that sometimes the jacket on that wire is bigger than.016 and can cause the wire to get stuck.The physician was just about where he wanted to be with the microcatheter however wanted a couple more centimeters so he removed the.016 fathom wire and inserted a.014 nitrex wire so he could remove the microcatheter and take off the touhy to gain the few centimeters he needed.When he did that, he noticed the tip of the microcatheter was damaged and could not be put back on the wire to reinsert.At that point he was given another progreat alpha 2.0 and they were able to complete the case without issue.The estimated blood loss was less than 250cc.The patient was in stable condition and the procedure outcome was successful.Additional information was received on-09-dec 2021: the procedure for the patient was a prostate artery embolization.

• Brand Name: TERUMO PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13310784
• MDR Text Key: 285760762
• Report Number: 9681834-2021-00259
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350727381
• UDI-Public: 04987350727381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: MC*PC2015Y
• Device Lot Number: 201210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .014 NITREX WIRE; .016 FATHOM WIRE
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White