MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 STANDARD STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Model Number	M00326510
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the ptfe ( polytetrafluoroethylene) coating of the subject guidewire was peeling from the proximal end.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 93cm, 143cm and 265cm from the proximal end.The guidewire ptfe coating was noted to be peeling at the proximal end.The core wire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.During functional inspection, the guidewire distal tip was reshaped.After several unsuccessful attempts the desired shape was achieved and was retained.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.The reported complaint was not confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the dispenser hoop was flushed before removing the guidewire.No resistance was encountered removing the guidewire from the dispenser hoop.There were no other difficulties encountered during the usage of the device that could have contributed to the issue.Analysis of the returned device found the tip of the guidewire had already been shaped.Kinks/bends were present at the proximal end.The guidewire distal tip was reshaped.After several unsuccessful attempts the desired shape was achieved and retained.Therefore, the as reported ¿guidewire distal tip poor shape retention¿ was not confirmed.The as analyzed ¿guidewire kinked/bent¿ has been 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.The guidewire ptfe coating was noted to be peeling at the proximal end.The peeling/scraping most likely occurred as a result of interaction with another device.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 analyzed ¿guidewire ptfe coating peeling¿ has been 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: SYNCHRO2-14 STANDARD STRAIGHT 300CM
• 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: 16931199
• Report Number: 3012931345-2023-00089
• Device Sequence Number: 12463857
• Product Code: DQX
• UDI-Device Identifier: 04546540688781
• UDI-Public: 04546540688781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053268
• 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): 05/15/2023

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: 07/18/2025
• Device Model Number: M00326510
• Device Catalogue Number: M00326510
• Device Lot Number: 0000156613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: Asian