MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SOFT PS 215CM; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Model Number	SSFT215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the ptfe coating of the guidewire (subject device) was peeled off.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 visual inspection, there was no attempt made to shape the tip.The guidewire was noted to be kinked/bent at 69cm and 188cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas to 50cm from the proximal end.The guidewire hydrophilic coating was noted to be rough.The core wire distal end was observed through the distal tip dome.The guidewire was soaked in water.After soaking the guidewire, it was inspected wet.The hydrophilic coating was intact.The guidewire distal tip revealed slight uneven swelling/bulge on its distal tip.When dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During functional inspection, the guidewire was advanced through a flushed demonstration microcatheter, friction was noted as the guidewire advanced towards the distal end of the microcatheter.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 confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the wire would not load into the microcatheter, when examined the guidewire appeared to be 'bumpy' at the distal end.During analysis, the guidewire was noted to be kinked/bent at 69cm and 188cm from the proximal end, and the guidewire ptfe coating was noted to be peeling in multiple areas to 50cm from the proximal end.The peeling 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 guidewire hydrophilic coating was noted to be rough.The guidewire was soaked in water.After soaking the guidewire, it was inspected wet.The hydrophilic coating was intact.The guidewire distal tip revealed slight uneven swelling/bulge on its distal tip, when dry after approximately 10 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.During the dimensional inspection, the od's were confirmed to be within specification when the device was both wet and dry.During the functional inspection, the guidewire was advanced through a flushed demonstration microcatheter, and slight friction was noted towards the distal end of the microcatheter.An assignable cause of ¿procedural factors¿ will be assigned to the as reported/as analyzed 'guidewire difficult to advance' and ¿guidewire hydrophilic coating surface rough' as well as the as analyzed ¿guidewire friction' and ¿device has cosmetic/appearance issue' since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.An assignable cause of ¿handling damage¿ will be assigned to the as analyzed ¿guidewire ptfe coating peeling' and ¿guidewire kinked/bent' 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: SYNCHRO SELECT-14 SOFT PS 215CM
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• 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: 16534902
• Report Number: 3012931345-2023-00045
• Device Sequence Number: 6388770
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202522
• 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): 03/13/2023

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: 10/30/2025
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 0000195451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL 10 MICROCATHETER (STRYKER).; PHENOM PLUS MICROCATHETER (MEDTRONIC).
• Patient Sex: Male