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

Catalog Number OL-XS25455M

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not returned, therefore, an evaluation of the actual device was unable to be conducted.Review of the picture provided by the user found that, in the area near the inserter, the urethane coat had been separated with resultant exposure of the core wire.Reproductive testing was conducted with a factory-retained sample of the involved product code/lot.The test sample was hold with fingers at the distal end and pulled out from the holder tube while the wire clip was attached to the holder tube.As a result, the urethane coat was separated with resultant exposure of the core wire.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.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.It was likely that the actual product, when taken out from the holder tube, was exposed to a tensile load to the distal end; as a result, it is likely that the separation of the urethane coat occurred with resultant exposure of the core wire.With no actual sample available for evaluation, however, the cause of occurrence could not be determined.(b)(4).

Event Description

The user facility reported that the involved single use guidewire was used pre-treatment.The guidewire was reported to have inner core protruding from the end of the guidewire, from the outer layer.The patient was not harmed.

• Brand Name: SINGLE USE GUIDEWIRE
• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11001735
• MDR Text Key: 221270266
• Report Number: 9681834-2020-00246
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: OL-XS25455M
• Device Lot Number: 190801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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