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

Model Number	SSFT215PRE
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unruptured aneurysm endovascular coil embolization procedure, after flushing the introducer sheath, when the surgeon inserted and pushed forward the subject guidewire a little resistance was felt in the middle.When the introducer sheath was advanced to the end of the guidewire, the tip of the introducer sheath was covered with a green fibrous foreign body.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent at 185cm and 201cm from the proximal end.The guidewire ptfe coating was noted to be peeling to 148cm from the proximal end.The guidewire was returned with an introducer.Ptfe coating peelings were noted in both ends of the introducer.The core wire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.Functional test: the guidewire was advanced through a flushed demonstration sl - 10 microcatheter, no anomalies were noted.The event guidewire ptfe coating peeling was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for 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 the issue was noted while transferring the guidewire into the hub of the microcatheter using introducer sheath while preparation outside the patient.Analysis of the returned device found an attempt had been made to shape the guidewire tip.The guidewire was noted to be kinked/bent.The guidewire was returned with the introducer.The guidewire ptfe coating was noted to be peeling to 148cm from the proximal end.The introducer was noted to have evidence of ptfe peeling on either ends.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 as reported and as analyzed ¿guidewire ptfe coating peeling¿ and the as analyzed defect guidewire kinked/bent 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.The reported defect guidewire friction was not confirmed during the analysis.It is possible that the ptfe scrapings noted may have contributed to the reported defect but this was not noted during the analysis of the returned device.An assignable cause of 'not confirmed' will be assigned as the issue included a returned product review which showed no evidence of either the alleged issue or any defect which could have contributed to the event.
Event or Problem Description
It was reported that during an unruptured aneurysm endovascular coil embolization procedure, after flushing the introducer sheath, when the surgeon inserted and pushed forward the subject guidewire a little resistance was felt in the middle.When the introducer sheath was advanced to the end of the guidewire, the tip of the introducer sheath was covered with a green fibrous foreign body.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 SOFT PS 215CM
• 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: 13232828
• Report Number: 3012931345-2022-00008
• Device Sequence Number: 4598896
• Product Code: MOF
• UDI-Device Identifier: 07613327508598
• UDI-Public: 07613327508598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/07/2022

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: 06/28/2024
• Device Model Number: SSFT215PRE
• Device Catalogue Number: SSFT215PRE
• Device Lot Number: 66779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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: INTRODUCER SHEATH (UNKNOWN)
• Patient Sex: Unknown