MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO SELECT-14 SUPPORT ST 300CM; WIRE, GUIDE, CATHETER

Model Number	SSUP300STR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that an intracranial pta (percutaneous transluminal angioplasty ) procedure was performed in a patient.During the procedure when the operator attempted to insert the subject guidewire into the introducer, the coating on the proximal side of the subject guidewire peeled off, therefore the use of the subject guidewire was discontinued.The subject guidewire was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that an intracranial pta (percutaneous transluminal angioplasty ) procedure was performed in a patient.During the procedure when the operator attempted to insert the subject guidewire into the introducer, the coating on the proximal side of the subject guidewire peeled off, therefore the use of the subject guidewire was discontinued.The subject guidewire was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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 18cm and 170cm from the proximal end.The guidewire ptfe coating was noted to be peeling in multiple areas to 115.5cm from the proximal end.The core wire distal end was observed through the distal tip dome.Hydrophilic coating was hydrated there were no anomalies noted.Functional test: a functional test was not required as the reported event was confirmed based on the device 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.The event was confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.Additional information indicates "when inserting the guidewire into the introducer, the coating on the proximal side peeled off, and use was discontinued".The device was prepared for use as per the directions for use, 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, continuous flush was set up and maintained throughout the clinical procedure and the introducer sheath was used during the guidewire insertion.Analysis of the returned device found an attempt had been made to shape the guidewire tip.The guidewire was returned and peeling of the ptfe was evident.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.It is possible that during this process the guidewire was unintentionally kinked.The as reported and as analyzed ¿guidewire ptfe coating peeling¿ and the 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.
Event or Problem Description
It was reported that an intracranial pta (percutaneous transluminal angioplasty) procedure was performed in a patient.During the procedure when the operator attempted to insert the subject guidewire into the introducer, the coating on the proximal side of the subject guidewire peeled off, therefore the use of the subject guidewire was discontinued.The subject guidewire was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO SELECT-14 SUPPORT ST 300CM
• 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: 13608889
• Report Number: 3012931345-2022-00036
• Device Sequence Number: 5833747
• Product Code: MOF
• UDI-Device Identifier: 07613327508628
• UDI-Public: 07613327508628
• 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): 05/19/2022

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: 05/03/2024
• Device Model Number: SSUP300STR
• Device Catalogue Number: SSUP300STR
• Device Lot Number: 63386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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: GUIDEWIRE INTRODUCER (STRYKER)
• Patient Sex: Unknown