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

Model Number	M0031681910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the coiling procedure for the right peri cavernous dural arteriovenous fistula, the distal fluoro saver marker on the subject microcatheter was detached inside the patient's anatomy.The detached fluoro saver marker was left inside the patient ¿s venous channel within the right petrous bone and was stable in position.The patient¿s current condition was unknown.No additional information was provided regarding the patient impact due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the distal shaft of the catheter was found to be kinked and flat/crushed at 1.5cm and 0.5 cm from the distal tip.The proximal marker band was seen to be present and in place.The catheter distal shaft was found to be stretched and the distal marker band was found to be detached from the catheter.The catheter hub was found to be intact.Functional testing was not carried out due to damage of the catheter.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.Additional information provided by the customer indicated that the device was prepared as per the dfu, the dispenser hoop was flushed before removing the catheter, there was no resistance encountered removing the catheter from the dispenser hoop, the procedure was completed by coils embolization to eliminate the right pericavenous dural arteriovenous fistula (avf) and its draining venous pathway and continuous flush was maintained for the duration of the procedure.The right eye symptom improved after endovascular treatment, no adverse clinical consequence.There was no need for any medical intervention nor retrieval of detached distal radiopaque marker, as it was left in the venous channel in petrous bone together with deployed coils and was stable in position.It was seen that the microcatheter was severely damaged, and the ro marker were detached.The damage noted to the device would be indicative of the as reported defects.The as reported and as analyzed 'ro marker(s) detached/separated/not visible under fluoroscopy' and as reported 'un-retrieved device fragments' as well as the as analyzed 'catheter shaft kinked/bent' and 'catheter shaft stretched' and 'catheter shaft flat/crushed' will be assigned procedural factors as these defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that during the coiling procedure for the right peri cavernous dural arteriovenous fistula, the distal fluoro saver marker on the subject microcatheter was detached inside the patient's anatomy.The detached fluoro saver marker was left inside the patient ¿s venous channel within the right petrous bone and was stable in position.The patient¿s current condition was unknown.No additional information was provided regarding the patient impact 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: 13365801
• Report Number: 3008881809-2022-00039
• Device Sequence Number: 11698412
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 22730979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown