MAUDE Adverse Event Report: TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirms that the device met all material, assembly and performance specifications.During visual inspection, the guidewire was noted to be kinked from the distal end.The torque device was attached from the proximal end.On removal of the torque device, the ptfe was peeled.The ptfe (polytetrafluoroethylene) flakes were visible under the cap of the torque device and on the surface of the torque device.Functional testing was not performed due to the damages noted to the device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging.The complaint was an out of box failure.A gateway balloon catheter was used in the procedure in conjunction with the subject device.Analysis of the returned device confirmed the guidewire was kinked at the distal end.It is probable the guidewire experienced excessive torque and manipulation during removal from the dispenser hoop which resulted in the observed damage.Analysis of the returned device also found the torque device accessory had been attached to the guidewire proximal end.On removal of the torque device the ptfe was found to have peeled off.It is probable the torque device was over tightened which resulted in the damaged ptfe.The as reported event guidewire kinked/bent, the as analyzed events guidewire distal end kinked/bent and guidewire ptfe coating peeling were assigned handling damage as the issues are due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
Analysis of the returned device found that the guidewire ptfe (polytetrafluoroethylene) coating peeling.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12734074
• Report Number: 3008853977-2021-00038
• Device Sequence Number: 1507722
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 25338878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GATEWAY BALLOON CATHETER (STRYKER)
• Patient Age: 67 YR