MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681910
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
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.Visual/microscopic inspections: the catheter hub and tip were intact.The catheter shaft was seen to be kinked at the distal end.Functional inspection: the device was flushed and a 0.0158" patency mandrel was advanced, restriction was felt 3cm from the hub.The device was flushed again and an attempt to advance distally also failed at the same location.The shaft was cut and what appeared to be ptfe (polytetrafluoroethylene) was removed.The reported event is covered in the device direction 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 defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that 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 confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.Also information provided indicted that one device was delivered without issue prior to the event.The catheter shaft was found to be kinked.The patency mandrel could not be advanced and the shaft was cut to order to investigate further.The catheter ptfe inner lining was removed from the shaft where the blockage was.The ptfe inner lining most likely peeled due to the difficulties encountered advancing the coils during the procedure and trying to advance the patency mandrel during analysis.The event probably occurred due to some procedural factors during use.The as reported 'catheter, difficulty advancing coil' as well as analyzed 'catheter shaft kinked/bent', 'catheter shaft friction' and 'catheter ptfe inner lining peeling' will be assigned procedural factors 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
The subject device was returned for analysis and the device investigation revealed that catheter ptfe (polytetrafluoroethylene) inner lining peeling.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19397729
• Report Number: 3008881809-2024-00233
• Device Sequence Number: 7689886
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042568
• 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
• Report Date (Section B): 05/24/2024

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: 10/22/2024
• Device Catalogue Number: M0031681910
• Device Lot Number: 23986820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER)
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: Asian