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

Model Number	M00326110
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of the 2 reports.
Event or Problem Description
It was reported that during an a-com cerebral aneurysm coil embolization procedure, physician inserted the catheter into the aneurysm using the jailed balloon technique and embolization was performed after placing a stent.He tried to change the position of the catheter using the subject guidewire and tried to re-insert the catheter into the aneurysm using trans cell technique.When the subject guidewire was removed it was seen that the coating was peeled off.It wasn't confirmed if the peeling was of the catheter or the subject guidewire.There might be some coating fragments left inside the patients anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.
Additional Manufacturer Narrative
The device history record (dhr) confirms that the device met all material, assembly, and performance specifications.During a visual inspection, the syringe contains a solution and on inspection, ptfe flakes were able to be found.The functional test cannot be performed due to no device or accessory were returned.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 there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, there was no resistance when the guidewire was taken out of the dispenser hoop, the guidewire was shaped 60 degrees, the continuous flush was set up and maintained throughout the clinical procedure, the flush was given inside the microcatheter at the time when the guidewire was inserted, the introducer sheath was used when inserting the guidewire, no friction or resistance was felt at the hub, the guidewire advanced/retracted without any excessive force and the patient¿s anatomy was normal tortuous.Only the syringe with coating-like material will be returned.The color of the coating material peeled off was dark bluish color.It is possible peeled material may be present in the patient¿s anatomy.It is unknown at present if the patient was affected as a result of the event."no health hazards have been identified at this time, but if the collected material is a microcatheter or guidewire coating, it may cause embolism".The patient¿s current condition is unknown.Product analysis found slivers of ptfe returned inside a syringe.The type of peeling noted is consistent with damage caused by backloading the guidewire into the introducer sheath.However, since the introducer sheath was not returned for analysis this could not be definitively assessed.While it is possible peeled material may be present in the patient¿s anatomy, this has not been confirmed and remains currently unknown.Therefore, a cause of undeterminable has been assigned to the as reportable ''guidewire ptfe coating peeling'' and ¿'un-retrieved device fragments'¿ and as analyzed "guidewire ptfe coating peeling".
Event or Problem Description
It was reported that during an a-com cerebral aneurysm coil embolization procedure, physician inserted the catheter into the aneurysm using the jailed balloon technique and embolization was performed after placing a stent.He tried to change the position of the catheter using the subject guidewire and tried to re-insert the catheter into the aneurysm using trans cell technique.When the subject guidewire was removed it was seen that the coating was peeled off.It wasn¿t confirmed if the peeling was of the catheter or the subject guidewire.There might be some coating fragments left inside the patients anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No additional information available.

• Brand Name: SYNCHRO2-14 SOFT PRE-SHAPED 200CM
• 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: 12531199
• Report Number: 3012931345-2021-00157
• Device Sequence Number: 13738159
• Product Code: DQX
• UDI-Device Identifier: 04546540688736
• UDI-Public: 04546540688736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: M00326110
• Device Catalogue Number: M00326110
• Device Lot Number: 0000059190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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: NEUROFORM ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER); UNKNOWN BALLOON; UNKNOWN COILS; NEUROFORM ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER); UNKNOWN BALLOON; UNKNOWN COILS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female