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

Model Number	M0031681910
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, there were no visual anomalies noted to the device.The catheter hub and tip were both intact.During functional inspection, a 0.023" pin gauge was verified to meet the catheter shaft when inserted into the catheter hub.The catheter was very difficult to flush, with blood exiting the catheter.An attempt was made to advance a 0.0158" patency mandrel through the catheter shaft but the mandrel would not advance past 73cm from the hub, so an attempt was made to advance the mandrel through the distal of the catheter but again the mandrel would not go past the blocked area of the catheter.The catheter was then soaked in warm water and once removed the catheter was still found to be blocked, so in an attempt to figure out what was causing the blockage the catheter was cut at 73.5cm from the hub and the mandrel advanced through again this time causing ptfe inner lining to exit 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 indicated 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 continuous flush was set up and maintained throughout the clinical procedure.Also additional information received indicated that the device was not prepared for use as per the directions for use which would have contributed to the event.The device could not be flushed during analysis.A patency mandrel was inserted into the catheter shaft but could not be advanced throughout the catheter shaft.The patency mandrel was advanced with force and blood exited the catheter shaft.An attempt to flush the device again was made but it could not be flushed.The catheter shaft was cut at the blocked area and ptfe liner was removed.The ptfe liner most likely became damaged with the force applied trying to advance the patency mandrel and coils.The as reported and as analyzed device difficult to flush as well as the as analyzed catheter shaft blocked/occluded and catheter ptfe inner lining peeling will be assigned use error as the device was not prepared for use as per the dfu.The investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user as there was a deviation from the supplied dfu that resulted in a different medical product response than intended by the manufacturer or expected by the user.
Event or Problem Description
Analysis of the returned device found that the subject microcatheter ptfe (polytetrafluoroethylene)coating was peeling.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• 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: 15593054
• Report Number: 3008881809-2022-00505
• Device Sequence Number: 19398954
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 10/13/2022

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: 10/03/2023
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 23211191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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: TARGET COIL (STRYKER)
• Patient Age: 41 YR
• Patient Sex: Female