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	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guidewire was noted to be kinked/bent at 29.3cm and 191cm, an attempt had been made to shape the guidewire tip, the guidewire ptfe coating was noted to be peeling in multiple areas to 31.3cm from the proximal end, 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 unclasped and collapsed dome were found at approximately between 4cm and 7cm from the distal end.The core wire distal end was observed through the distal tip dome.During analysis the guidewire was kinked at 7cm from the distal end.An attempt was made unsuccessfully to advance the guidewire through a demonstration sl-10 microcatheter, the guidewire would not advance beyond 7cm from the distal end.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.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 the event occurred during preparation outside the patient.The device was returned, and it was confirmed to be kinked causing difficulty to advance through a demonstration sl-10 microcatheter, confirming the event.It is probable that the device was damaged during unpacking of the device or during preparation, causing the reported event, it is probable that the ptfe coating was peeled due to under tightening of the torque device.An assignable cause of handling damage will be assigned to the reported and analyzed ¿guidewire difficult to advance¿ and to the analyzed ¿guidewire kinked/bent¿, ¿guidewire ptfe coating peeling¿, ¿guidewire hydrophilic coating surface rough¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Analysis of the returned device found the subject guidewire ptfe coating was peeling/peeled.There were no clinical consequences to the patient reported as a result of this event.

• 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: 12921885
• Report Number: 3012931345-2021-00200
• Device Sequence Number: 17428927
• 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): 12/02/2021

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: 08/31/2022
• Device Model Number: M00313020
• Device Catalogue Number: M00313020
• Device Lot Number: 0000050840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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)
• Patient Age: 59 YR
• Patient Sex: Female