MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-45CM; WIRE, GUIDE, CATHETER

Model Number	M00313020
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found the subject guidewire (ptfe) polytetrafluoroethylene coating was peeling/peeled.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, an attempt had been made to shape the guidewire tip; the guidewire was noted to be kinked/bent at 33cm from the proximal end, a ripple of kinks/bends were noted from 174cm to 181cm from the proximal end, the guidewire distal section and hydrophilic coating was examined along its length.The guidewire hydrophilic coating was found to be rough; the guidewire (ptfe) polytetrafluoroethylene coating was noted to be peeling in multiple areas to 51cm from the proximal end, the core wire distal end was observed through the distal tip dome, and hydrophilic coating was hydrated there were no anomalies noted.A functional test was not required.The reported event was confirmed during the device analysis.The device failed to meet specifications when returned.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 indicated there was no damage noted to the packaging prior to opening the packaging and this was an out of box failure.There was no patient involvement, and the device was not in use on the patient at the time of the event.The patient¿s anatomy was moderately tortuous.An excelsior sl-10 microcatheter was used in the procedure in conjunction with the subject device.The procedure was completed successfully.Analysis of the returned device found ripples of kinks/bends along the distal end of the guidewire and at 33cm from the proximal end.The hydrophilic coating of the synchro wire was also found to be rough.It is probable the device experienced significant manipulation during removal from the dispenser hoop.Scraping and peeling of the (ptfe) polytetrafluoroethylene was also evident in several sections from the proximal end to approximately 51 cm from the proximal end and most likely occurred as a result of interaction with another device possibly the dispenser hoop or introducer sheath.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.The as reported ¿guidewire deformed¿ and as analyzed defects ¿guidewire kinked/bent¿, ¿guidewire hydrophilic coating surface rough' and ¿guidewire ptfe coating peeling¿ will be assigned handling damage as the issue is 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.

• Brand Name: SYNCHRO-14 STRAIGHT 200-45CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13344865
• Report Number: 3012931345-2022-00016
• Device Sequence Number: 16559681
• Product Code: DQX
• UDI-Device Identifier: 07613252186939
• UDI-Public: 07613252186939
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032146
• 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): 01/25/2022

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: 02/24/2022
• Device Model Number: M00313020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000061892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2019
• 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: EXCELSIOR SL-10 (STRYKER MANUFACTURER)
• Patient Age: 58 YR
• Patient Sex: Female