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	09/03/2023
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.During visual inspection, the catheter shaft was found to be kinked/bent at 70cm from the hub tip, the catheter shaft was noted to be blocked/occluded with material 7cm from the hub, and the catheter hub and tip were both intact.During a functional inspection, a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The microcatheter was flushed, a 0.0158" patency mandrel was advanced through the microcatheter, the mandrel got stuck 7cm from the hub tip, the catheter was cut, and material was removed from the catheter shaft.The material appeared to be ptfe (polytetrafluoroethylene) inner lining from the catheter.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 was confirmed to be in good condition during preparation/prior to use on the patient and the catheter was flushed to facilitate the guidewire insertion.The catheter shaft was found to be kinked and the patency mandrel could not advance past 7cm into the catheter shaft.There was material removed from the catheter shaft which appeared to be ptfe lining of the catheter.The ptfe would have been damaged when the resistance was encountered during the procedure and during analysis.The catheter shaft was found to be kinked/bent.The as reported 'catheter difficulty advancing guidewire' as well as the as analyzed 'catheter shaft blocked/occluded', 'catheter shaft friction', 'catheter shaft kinked/bent' 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 factors during use, the product performance was limited.
Event or Problem Description
The catheter (subject device) was returned for analysis, and it was discovered that the catheter shaft (subject device) was blocked with ptfe (polytetrafluoroethylene) lining from the catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 18327425
• Report Number: 3008881809-2023-00583
• Device Sequence Number: 7035275
• 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): 12/14/2023

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: 08/21/2024
• Device Catalogue Number: M0031681910
• Device Lot Number: 23847045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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 GUIDEWIRE (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian