MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Model Number	M00316310
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection,the guidewire was returned broken in 2 segments (34.8cm distal segment and 284.5cm proximal segment).An attempt had been made to shape the guidewire tip.The guidewire ptfe coating was noted to be peeling in multiple area to 167cm from the proximal end.In the distal segment, 34.8cm of the nitinol tubing was returned broken, there was no core wire exposed.In the proximal segment, 284.5cm of guidewire was returned broken, core wire exposed.The corewire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.Functional inspection was not required.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 this was an out of box failure.The dispenser hoop was flushed before removing the guidewire, there was no resistance encountered removing the guidewire from the dispenser hoop.Other devices used in the procedure in conjunction with the subject device were guidewire and balloon catheter.Analysis of the returned device found the guidewire tip appeared to have been shaped, the device was broken in 2 fragments, 34.8cm from the distal end and 284.5cm from the proximal end.The nitinol tubing and core wire were broken which indicates the device encountered a significant force during preparation.In addition analysis of the returned device found scraping and peeling of the ptfe was evident in several sections from the proximal tip to approximately 167cm from the proximal end and 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 reported and as analysed ¿guidewire distal tip broken/fractured during preparation¿ in addition to the as analysed ¿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.
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that ptfe coating of the subject guidewire was peeled off.Therefore, this event meets the requirements of a reportable event with an awareness date of (b)(6) 2022.

• Brand Name: SYNCHRO-10 STRAIGHT 200CM
• 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: 13827543
• Report Number: 3012931345-2022-00051
• Device Sequence Number: 2149977
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/18/2022

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: 06/07/2023
• Device Model Number: M00316310
• Device Catalogue Number: M00316310
• Device Lot Number: 0000065322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2022
• Initial Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Race: Asian