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

Catalog Number OL-XA25455

Device Problem Crack (1135)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number: 16k.Implanted date: device was not implanted.Explanted date: device was not explanted.Name and address- (b)(6).The actual sample was received for evaluation.The actual sample was not clear whether it was infectious or not.The inspection of it was limited as follows.Visual inspection of the actual sample through the plastic bag found that the outer layer had peeled off from about 120 mm to about 140 mm from the distal end.There was no other anomaly in other areas.Simulation test: based on experience, it is known that, while a guidewire is inserted in an endoscope and the forceps elevator is in the lifted-up position, when the guidewire is pushed or pulled, a peeling of outer layer (ptfe coat) similar to that on the actual sample may occur.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: stop the operation if you experience excessive resistance or obstruction while inserting the guidewire into the endoscope.Attempting to force the guidewire into the endoscope may damage to its surface coating.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 was likely that the crack in the middle of the guidewire as pointed out referred to the peeling of outer layer of approx.120 mm -140 mm from the distal end of the actual sample.As a possible cause of occurrence, it was likely that the actual sample might have been abraded leading to the peeling of outer layer when the actual sample in the state of coming into strong contact with a hard object (e.G.Concurrently used device) may have been subjected to pushing and pulling manipulation.However, since the actual sample was unknown whether infectious or not, close examination of it could not be performed, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the single use guidewire was used during the investigation.During the erop case, they found a crack in the mid part of the guide wire in the endoscopic image.It has been confirmed that no detached coating fragments remain in the patient's body.The procedure was completed successfully.The patient was not harmed.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 13058930
• MDR Text Key: 290453375
• Report Number: 9681834-2021-00249
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 210605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2021
• 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: JF-260V