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

Model Number	M0031681910
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During ic-pc (internal carotid-posterior communicating artery) ruptured aneurysm procedure after alignment of coil detach marker with the inverted t beyond the proximal marker of microcatheter (subject device), the coil could not be removed out of the microcatheter for detachment because the coil remained in the catheter tip.The coil was removed, and a new coil was inserted.The subject catheter markers were aligned in the same way, but the second coil also could not be removed out of the microcatheter.There was more than 3 cm between the tip marker and the proximal marker of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The edhr (electronic device history record) for each lot is created and maintained in mes (manufacturing execution system).Automated controls within the mes system ensure that all product is manufactured in accordance to the dmr (device master record).There are automated controls in place to ensure that the device and labelling meets specification when released.The lot number was confirmed with the packaging returned with the device and the hub.Visual inspection indicated that the catheter proximal shaft was intact.The catheter distal was stretched.The catheter tip was intact.The catheter hub was intact.Functional inspection indicated that the catheter was flushed and the returned coil was advanced without issue.The coil did not exit the microcatheter due to the stretched shaft.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 damage noted to the device would be indicative of the as reported defect.It was seen that the catheter distal shaft was stretched which would account for makers bands to be out of alignment.This defect was a direct cause of the reported issue.The catheter most likely stretched during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analyzed defect.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned.
Event or Problem Description
During ic-pc (internal carotid-posterior communicating artery) ruptured aneurysm procedure after alignment of coil detach marker with the inverted t beyond the proximal marker of microcatheter (subject device), the coil could not be removed out of the microcatheter for detachment because the coil remained in the catheter tip.The coil was removed, and a new coil was inserted.The subject catheter markers were aligned in the same way, but the second coil also could not be removed out of the microcatheter.There was more than 3 cm between the tip marker and the proximal marker of the microcatheter.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
• MDR Report Key: 10646146
• Report Number: 3008881809-2020-00293
• Device Sequence Number: 2604657
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/16/2020

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: 06/15/2021
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 21533722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 TARGET COIL (STRYKER)