MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681900
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter (subject device) was returned for analysis and was examined.During device investigation and analysis, it was discovered that the catheter (subject device) ptfe (polytetrafluoroethylene) inner lining was identified in the shaft.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The lot number was confirmed with the packaging returned with the device and the hub.During visual inspection, the catheter shaft was kinked in multiple areas.The catheter tip was intact.There was procedural fluid in the hub flow path.There was no visible delamination in the hub.During functional inspection, a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The catheter could not be flushed, a 0.0158" patency mandrel was advanced through the catheter and stopped 6cm from the proximal of the hub.The patency mandrel was attempted to be advanced distally and stopped at the same location.The catheter shaft was cut 6cm from the proximal of the shaft and material was identified in the catheter shaft.The patency was inserted into the hub and material which appeared to be ptfe (polytetrafluoroethylene) inner lining exited the cut shaft.Water was placed on the material to ascertain if it would dissolve, the material did not dissolve.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received indicated that the device was prepared for use as per the directions for use, continuous flush was maintained throughout the clinical procedure.It was a left anterior carotid artery (aca) a2 thrombus procedure.Used guidewire to deliver subject microcatheter to left aca a3.Withdrew the guidewire and then used subject microcatheter to deliver retriever.The ifu (instructions for use) of this stent states it could go through 0.0165 microcatheter but the stent could not be advanced into subject microcatheter.Replaced the subject microcatheter with another one to go through same stent to finish the procedure successfully.There was no reported friction delivering the guidewire to deliver the subject microcatheter.The catheter shaft was kinked.The catheter could not be flushed, a 0.0158" patency mandrel was advanced through the catheter and stopped 6cm from the proximal of the hub.The patency mandrel was attempted to be advanced distally and stopped at the same location.The catheter shaft was cut 6cm from the proximal of the shaft and material was identified in the catheter shaft.The patency was inserted into the hub and material which appeared to be ptfe inner lining exited the cut shaft.Water was placed on the material to ascertain if it would dissolve, the material did not dissolve.It is likely the ptfe inner layer was damaged when resistance was felt advancing the stent during the procedure.The as reported event of catheter hub friction as well as the analyzed events of catheter shaft kinked/bent, catheter shaft blocked/occluded and catheter ptfe inner lining peeling will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 20517619
• Report Number: 3008881809-2024-00496
• Device Sequence Number: 7880931
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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): 10/23/2024

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: 08/09/2025
• Device Catalogue Number: M0031681900
• Device Lot Number: 24457413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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: SYNCHRO SELECT GUIDEWIRE (STRYKER).
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: Asian