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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The user facility reported that while in a procedure the progreat 2.4 150cm broke apart while still on the wire.The tech in the case reported that the doctor was being very rough with the catheter and feels that he might have been the reason it fell apart however it appears that the progreat became stuck to the wire and when he tried to remove the catheter it broken near the wire.The patient was stable with no problems.The procedure outcome was successful.Additional information was received on 06december2021.The type of procedure being performed was a tibial arterial percutaneous transluminal angioplasty (pta).The device broke while in the patient.The v14 wire had to be removed with the residual progreat catheter on it.Testing was performed to ensure the broken portion was removed completely.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Manufacture date - unknown due to unknown lot number.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record could not be performed since the involved lot number was unknown.Regarding the involved product code, the complaint file for the past two years (from december 2019 to november 2021) was reviewed.No other similar report was confirmed.(b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual progreat device and concurrently used guidewire were returned to ashitaka for evaluation.Visual inspection confirmed that the actual catheter sample had been broken apart.The proximal portion measured 1325 mm in length.The distal portion was broken further into three pieces, and they were located on the concurrently used guidewire at about 1330 mm - 1400 mm, 1460 mm - 1520 mm, and 1610 mm - 1620 mm from the distal end of the guidewire.They were referred to as fragment-1, fragment-2, and fragment-3 respectively in this report.Magnifying inspection of the actual sample obtained the following findings.Fragment-1: the inner layer and the reinforcing coil had been buckled and elongated.The outer layer had been broken off.Red foreign substance was clogging in the lumen.Fragment-2: the inner layer and the reinforcing coil had been buckled and elongated.The outer layer had been broken off.Fragment-3: the outer layer had been broken off and the reinforcing coil had been fractured.Distal end of the proximal portion: the reinforcing coil had been elongated and the outer layer had been broken off.Electron microscopic inspection of the actual sample obtained the following findings.Fragment-1: the outer layer had been ripped.Fragment-2: the outer layer had been abraded, ripped and turned back.Fragment-3 and the proximal end of the guidewire: the outer layer had been ripped and turned back.Based on the above findings, it was considered that some hard object might have come into contact with the actual sample applying an abrasion load to the involved area.The red foreign substance found in fragment-1 was subjected to component analysis by ft-ir and confirmed to be casein (protein), which suggested that it was blood clot.From this, it was presumed that blood clots were adhering in the catheter lumen and the guidewire surface due to some factors.The inner diameter and the outer diameter were measured on the undamaged area and no dimensional anomaly was confirmed.The outer diameter of the guidewire was measured to be 0.018 inch, which is the diameter compatible to the actual catheter.In order to confirm the mechanism of breakage and separation of the actual catheter sample, the following simulation tests were conducted.Simulation test 1: a 0.018-inch guidewire was inserted in a factory-retained catheter sample.Assuming that the catheter and the guidewire were stuck due to adhesion of blood clots, a tensile load was applied to the catheter in the proximal direction while the distal end of the catheter was trapped.As a result, the catheter was stuck on the guidewire and elongated.In order to release the sticking state, the proximal shaft was grasped and pushing and pulling load was applied repeatedly to the catheter.As a result, breakage of the outer layer occurred in one section only.Buckling and elongation of the inner layer and reinforcing coil also occurred.However, ripping, turn back, or multiple breaks in the outer layer as seen in the actual sample were not reproduced in this simulation test.Simulation test 2: a 0.018-inch guidewire was inserted in a factory-retained catheter sample.Assuming that the catheter and the guidewire were stuck due to adhesion of blood clots, a tensile load was applied to the catheter in the proximal direction while the distal end of the catheter was trapped.As a result, the catheter was stuck on the guidewire and elongated.In order to release the sticking state, the proximal shaft was grasped and pushing and pulling load was applied repeatedly to the catheter in a manner that the abrading load was applied to the surface of the distal shaft.This operation was performed intermittently in multiple locations.As a result, the outer layer of the catheter broken off in multiple places with ripping and turn back.In addition, buckling and elongation of the inner layer, buckling, elongation, and fracture of the reinforcing coil occurred.These conditions were very similar to those of the actual sample.Based on the investigation result, as one of the possibilities, this case was considered to be caused by the following mechanism.Blood clots adhered to the inner surface of the actual sample and the outer surface of the guidewire for some reason, causing both devices to be stuck to each other.The catheter in that sticking state was subjected to removal operation.As a result, the catheter was elongated and the sticking state was aggravated.In order to release the sticking state, pulling and pushing load was applied to the catheter repeatedly while the distal section and the proximal shaft were grasped, in a manner that the distal shaft surface was exposed to an abrading load.As a result, the outer layer was broken off with rips and turn back.In addition, this manipulation was performed intermittently in multiple locations, which resulted in the breakage of outer layer in multiple locations.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.Ifu states: "if any resistance is felt, do not remove the micro catheter system 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13108117
• MDR Text Key: 287897733
• Report Number: 9681834-2021-00242
• Device Sequence Number: 1
• Product Code: DQO
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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 Model Number: N/A
• Device Catalogue Number: MC*PV2415Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: FATHOM WIRE - BOSTON SCIENTIFIC; PROGREAT
• Patient Age: 84 YR
• Patient Sex: Male