MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number OL-XA25455M

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter info: unknown.The actual device was returned for evaluation.Visual inspection upon receipt revealed that the urethane outer layer had been sheared off on 0 - approximately 2mm from the distal end of the device, where the core wire was exposed.It was also found that the gold coil had been fractured.Electron microscopic inspection of the distal extremity of the core wire revealed that the surface of the cut cross-section had the evidence that the core wire had been cut and processed with the dedicated machine on the production floor.The above findings demonstrate that the actual device is missing the urethane outer layer and the gold coil with no fractured or missing portion of the core wire.Magnifying and electron microscopic inspection of the fracture end of the urethane outer layer found that the configuration of the fracture was consistent with that generated when the urethane outer layer was ripped off.Exposure of the gold coil was noted.Around the fracture, there was no any anomaly, such as a scratch, which could have been a trigger of the occurrence of the fracture.Electron microscopic view of the fracture end of the gold coil found that the coil had become thinner toward the fracture end.The outside diameter was measured on the undamaged segment and confirmed to meet manufacturer specifications.Functional testing was conducted: a guide wire sample was pulled out of the holder with the wire clip still attached to the holder by pinching the distal segment of the guide wire with the fingers and pulling the guide with excessive force.As the result, the urethane outer layer and the gold coil became fractured and the core wire was exposed.Electron microscopic inspection of the fracture end of the gold coil found that the coil had become thinner toward the fracture end.The damage similar to that was observed on the actual device was duplicated.A review of the manufacturing record and the shipping inspection record of the involved product/lot# combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely the actual device was subjected to excessive pulling force on the distal segment, resulting in the reported fracture of the urethane outer layer and the gold coil.However, the exact cause of the reported event cannot be definitively determined.Ifu states: remove the wire clip from the holder.Holding the guidewire, push the guide wire in the direction of the inserter to take out the guidewire from the holder.Do not pull the guidewire toward where the wire clip was attached." (b)(4).

Event Description

The user facility reported that while the user was preparing for the operation, the user found that the hydrophilic coating of the distal end was off and the core wire was exposed.There was no patient involvement.The procedure outcome is unknown.Final patient impact is unknown.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7946378
• MDR Text Key: 123814459
• Report Number: 9681834-2018-00174
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: 04953170358241
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2018

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: 03/31/2021
• Device Catalogue Number: OL-XA25455M
• Device Lot Number: 180406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• 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