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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the shipping inspection records of the involved product code/lot# combination was conducted with no findings.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 involved progreat broke in the patient.The procedure outcome and patient condition were not reported.

Event Description

Additional information was received on 28jul2020.The microcatheter was inserted into patient.When manipulating, it was seen on fluoroscopy that a fragment was stuck in the patient.It was removed via a snare.The patient recovered without further complications.The procedure was completed successfully.

Manufacturer Narrative

This report is being submitted as follow up no.1.H6: patient code: 3191: device was in patient; however, the device was removed.The actual sample was received for evaluation.Visual inspection revealed that catheter had been fractured and the distal end had been missing.The total length was measured approximately 1330mm (distal portion was 175mm and the main body was 1155mm).Compared to the length of a current product sample (approximately 1300mm), the actual sample had been elongated by 30mm or more; therefore, the length of the distal missing portion was impossible to be measured.Magnifying inspection of the distal end of the distal portion (fracture-end a) revealed that the inner layer and the stainless-steel reinforcement were exposed by having been elongated from the fractured outer layer.Magnifying inspection of the proximal end of the distal portion (fracture-end b) revealed that the outer layer had been deformed in a tapered shape.The stainless-steel reinforcement was exposed by having been elongated.Magnifying inspection of the distal end of the distal portion (fracture-end c) revealed that the outer layer had been elongated.The inner layer and the stainless-steel reinforcement were exposed by having been elongated.Electron microscopic inspection of fracture-end a revealed some abrasion generated on the outer layer surface.This inferred that a hard object came into contact with that area.Electron microscopic inspection of fracture-end b revealed some tears generated in the outer layer.Electron microscopic inspection of fracture-end c revealed no anomaly that could have contributed to the generation of the fracture, such as a scratch.Reproductive testing was performed and a factory-retained sample from the involved product code/lot# was trapped at the distal end, and the hub side was exposed to a pulling load.As a result, the outer layer was fractured.When a further pulling force was applied, the inner layer and the stainless-steel reinforcement were elongated starting from the fracture end of the outer layer and exposed.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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that when the actual catheter was removed from the patient, the tip portion was trapped by some kind of hard object or a tortuous vessel, and in that state, it was exposed to an excessive tensile load, which resulted in the fracture of the outer layer; it is likely that inner layer and the stainless steel reinforcement were exposed from the fracture end of the outer layer and fractured.However, the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr 2243441-2020-00049 for the importer report.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10270048
• MDR Text Key: 201607347
• Report Number: 9681834-2020-00132
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350781215
• UDI-Public: 04987350781215
• Combination Product (y/n): N
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: MC*PB2413Y
• Device Lot Number: 200121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GT WIRE
• Patient Outcome(s): Other
• Patient Age: 51 YR