MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an mca (middle cerebral artery) stenosis case, after puncturing the right femoral artery and placing the catheter to the mca (middle cerebral artery) m2 under the guidance of the subject guidewire, abnormal manipulation was observed.The operator withdrew the subject guidewire and discovered that its hydrophilic coating had peeled off.The physician replaced it with a new device and continued the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was noted to be kinked/bent, the guidewire (ptfe) polytetrafluoroethylene coating was noted to be damaged approx.44cm from the proximal end.There were no anomalies noted to the distal hydrophilic coating.The core wire was observed through the distal tip dome.During a functional inspection, the guidewire was soaked in warm water the demo microcatheter was flushed and the guidewire was advanced with slight friction.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 reported hydrophilic coating peeling was not confirmed; however, it was noted that the ptfe coating was peeled, it is likely that this was reported as being hydrophilic coating, therefore the reported event can be confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that during delivery the manipulation of the guidewire was abnormal.The operator withdrew the guidewire to check and found the tip coating of it peeled off.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, 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 patient¿s anatomy was moderately tortuous.The device was returned, and it was not confirmed that the hydrophilic coating was peeling, however it was confirmed that the ptfe coating was peeled, it is likely that this is the reported anomaly.There was kinking noted to the guidewire and slight friction was experienced when the device was hydrated and advanced though a demonstration microcatheter.The damage noted to the ptfe coating is indicative of backloading of the guidewire into the introducer causing skiving of the pfte coating, this is unlikely to have caused or contributed to the friction experienced and the kinking to the guidewire.An assignable cause of handling damage will be assigned to the analyzed 'guidewire ptfe coating peeling.' as the reported hydrophilic coating peeling was not confirmed, an assignable cause of not confirmed will be assigned to the reported 'hydrophilic coating peeling.' it is probable that the patient¿s anatomy may have caused the kinking noted to the guidewire and friction noted during advancement.An assignable cause of procedural factors will be assigned to the reported and analyzed 'guidewire difficult to advance' and to the analyzed 'guidewire kinked/bent', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during an mca (middle cerebral artery) stenosis case, after puncturing the right femoral artery and placing the catheter to the mca (middle cerebral artery) m2 under the guidance of the subject guidewire, abnormal manipulation was observed.The operator withdrew the subject guidewire and discovered that its hydrophilic coating had peeled off.The physician replaced it with a new device and continued the procedure without any clinical consequences to the patient.

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 19779011
• Report Number: 3012931345-2024-00129
• Device Sequence Number: 8110699
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: (01)07613252186946(17)231209(10)0000096010
• 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): 10/29/2024

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: 12/09/2023
• Device Catalogue Number: M00313310
• Device Lot Number: 0000096010
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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: 8F SHEATH (NON-STRYER); XT-27 CATHETER (STRYKER)
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Race: Asian