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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure while the physician removed the subject guide wire from the microcatheter its ptfe coating peeled off from the distal end.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure while the physician removed the subject guide wire from the microcatheter its ptfe coating peeled off from the distal end.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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.The device was returned within a dispenser coil.The lot number was confirmed with the packaging returned with the device.The torque device, insertion tool or microcatheter used with the guidewire were not returned.During the visual inspection, the guidewire distal tip was shaped.The guidewire distal section and hydrophilic coating was examined along its length.The guidewire hydrophilic coating was checked with the wet fingers.Peeling and bubbles with uncollapsed and collapsed dome were found at approximately between 2.5cm between 0cm and 23.0cm from the distal end.The hydrophilic coating was broken 12.3cm from the distal end with the core wire exposed and stretched, but intact and not broken.The guidewire ptfe coating was examined under magnification and the ptfe was damaged and was peeled/scraped off in several places along its proximal section between approximately 22.5cm to 32.0cm section (from its proximal end).Functional testing was not done as the device was damaged.The reported event was confirmed based on the device analysis.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 indicates there was no damage noted to the packaging, the device was confirmed to be in good condition during/after unpacking and preparation, the device prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure, an excelsior sl-10 microcatheter was used in the procedure in conjunction with the subject device, the patient¿s anatomy was not tortuous, the peeling occurred after the procedure while removing the guidewire wire from the microcatheter, the guidewire ptfe coating was peeling and the physician was unaware of the reason what caused the peeling.Analysis of the returned device found the ptfe was peeling which was most likely due to the torque device being insecurely fastened causing it to drag down the wire during use.The hydrophilic coating of the subject synchro wire was also found to be damaged, exposing a stretched core wire.In addition, bubbling and peeling were also noted which confirms the reported event.However, based on the review and analysis of the available information, the cause of this issue cannot be definitively determined.Therefore, a cause of 'undeterminable' has been assigned to the as reported and as analyzed events.

• 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
• MDR Report Key: 10505761
• Report Number: 3012931345-2020-00134
• Device Sequence Number: 3538402
• 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,Followup
• Report Date (Section B): 11/03/2020

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: 05/01/2021
• Device Model Number: M00313020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000026349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICRO CATHETER (STRYKER); SL-10 MICRO CATHETER (STRYKER)
• Patient Age: 50 YR