MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when shaping the subject guidewire with shaping needle, the coating of the subject guidewire peeled off.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker/ returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿ updated.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the subject guidewire was found to be kinked/bent.The subject guidewire tip was noted to be broken/fractured and stretched.The subject guidewire ptfe (polytetrafluoroethylene) was seen to be peeling approx.30 cm from the proximal end.The core wire distal end was observed through the distal tip dome.The reported complaint was confirmed based on analysis.The subject guidewire device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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, while shaping the subject guidewire with shaping needle, the subject guidewire ptfe coating peeled off.Additional information provided by the customer indicated the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The subject guidewire 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.The patient's anatomy was moderately tortuous.The subject guidewire device was returned, and it was confirmed that the guidewire ptfe coating was peeling, also additional information by customer indicated that torque device was also used.The peeling noted to the ptfe coating is an indicative of interaction with an under tightened torque device.An assignable cause of handling damage will be assigned to the reported and analyzed ¿guidewire ptfe coating peeling¿, 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.During analysis, the subject guidewire was noted to be kinked/bent and broken/fractured.The subject guidewire was also observed to be stretched.An assignable cause of handling damage will be assigned to the analyzed ¿guidewire distal tip broken/fractured during preparation¿, ¿guidewire kinked/bent¿, and ¿guidewire distal tip stretched¿, 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.
Event or Problem Description
It was reported that when shaping the subject guidewire with shaping needle, the coating of the subject guidewire peeled off.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• 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: 20507710
• Report Number: 3012931345-2024-00188
• Device Sequence Number: 21124882
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: (01)07613252186922(17)250705(10)0000451808
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 12/26/2024

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: 07/05/2025
• Device Catalogue Number: M00313010
• Device Lot Number: 0000451808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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: SL 10 MICROCATHETER (STRYKER)
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Race: Asian