MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO2-14 SOFT PRE-SHAPED 200CM; COMMON DEVICE NAME: WIRE, GUIDE, CATHETER.

Model Number	M00326110
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
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 cerebral aneurysm embolization procedure, while preparation of catheter with guidewire, operator felt resistance and guidewire (subject device) did not pass through the catheter even with the entire purging process.The doctor commented that the guidewire did not have the hydrophilic coating.The doctor replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during cerebral aneurysm embolization procedure, while preparation of catheter with guidewire, operator felt resistance and guidewire (subject device) did not pass through the catheter even with the entire purging process.The doctor commented that the guidewire did not have the hydrophilic coating.The doctor replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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 subject device is not available; therefore, visual and functional testing cannot be performed.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.It was reported that during preparation of the synchro guidewire (subject device), resistance was detected when inserting the guidewire into the excelsior microcatheter.The doctor commented that the guidewire did not have hydrophilic coating.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, and the procedure was completed using another synchro guidewire.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during cerebral aneurysm embolization procedure, while preparation of catheter with guidewire, operator felt resistance and guidewire (subject device) did not pass through the catheter even with the entire purging process.The doctor commented that the guidewire did not have the hydrophilic coating.The doctor replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The lot number was not confirmed as the packaging was not returned with the device.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.Visual/microscopic inspection indicated that the guidewire distal tip appeared to have been shaped.The guidewire hydrophilic coating was examined along its length with wet fingers.The coating was present on the guidewire and no anomaly was noted.The guidewire ptfe coating was examined under magnification and no anomaly was noted.The core wire was visible inside the dome.Functional inspection indicated that the guidewire was inserted and advanced through a demonstration sl-10 microcatheter without issue.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.It was reported that during preparation of the synchro guidewire (subject device), resistance was detected when inserting the guidewire into the excelsior microcatheter.The doctor commented that the guidewire did not have hydrophilic coating.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, and the procedure was completed using another synchro guidewire.No anomalies were noted to the returned device during analysis.The hydrophilic coating was present on the guidewire and the guidewire was inserted and advanced through a demonstration microcatheter without issue.Not confirmed will be assigned to the as reported hydrophilic coating peeling and guidewire difficult to advance since the investigation included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: SYNCHRO2-14 SOFT PRE-SHAPED 200CM
• Common Device Name: 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: 11048133
• Report Number: 3012931345-2020-00222
• Device Sequence Number: 1265452
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K053268
• 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,Followup
• Report Date (Section B): 03/23/2021

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: 01/08/2023
• Device Model Number: M00326110
• Device Catalogue Number: M00326110
• Device Lot Number: 00039015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/27/2021; 03/08/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/08/2021; 03/23/2021
• 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: EXCELSIOR MICROCATHETER (STRYKER).; EXCELSIOR MICROCATHETER (STRYKER)