MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO 2/14 200 CM SOFT PRESHAPED; WIRE, GUIDE, CATHETER

Catalog Number	M00326110
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported during preparation, small pieces of coating from the guidewire were noticed after backloading into an inserter.Another guidewire was used to complete the procedure.There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found the small bubbles on the guidewire distal section,and the ptfe (polytetrafluoroethylene) was peeled off from the proximal end.During functional testing, a slight friction was encountered when advancing the wire through a demo microcatheter.Additional information provided by the customer indicated that the guidewire was confirmed to be in good condition after unpacking.The customer observed the ptfe coating peeling while back loading the guidewire through the insertion tool.Back loading the guidewire through the insertion tool is not recommended as it poses a risk of scrapping of the guidewire coating.Based on the available information and device analysis, it seems that the ptfe coating was scrapped off of the guidewire with the insertion tool.The act of back loading may have resulted in a different medical product response than expected by the user.Therefore, a cause of use error is assigned to the reported and analyzed code ptfe coating peeling.The bubbles found on the guidewire distal section may have caused the friction encountered during the advancement of the guidewire through the demo microcatheter.However, the review of the available information failed to identify the cause of the bubbles.Therefore, a cause of undeterminable has been assigned to the analyzed codes guidewire coating issue (bubbles on distal section) and guidewire friction.
Event or Problem Description
It was reported during preparation, small pieces of coating from the guidewire were noticed after backloading into an inserter.Another guidewire was used to complete the procedure.There were no clinical consequences to the patient due to the reported event.

• Brand Name: SYNCHRO 2/14 200 CM SOFT PRESHAPED
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 7931873
• Report Number: 3012931345-2018-00015
• Device Sequence Number: 13815367
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/28/2018

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: 05/23/2021
• Device Catalogue Number: M00326110
• Device Lot Number: 0000009134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1