MAUDE Adverse Event Report: STRYKER NEUROVASCULAR EXCELSIOR SL-10; CATHETER, PERCUTANEOUS

Model Number	M0031681900
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per report: distal portion of the catheter was left in the patient post-procedure.Excerpts from operative report: it was determined that the sl-10 was in optimal position for embolization of the right mma [middle meningeal artery].Next an nbca [n-butyl 2-cyanoacrylate] kit (trufill/j&j) was open and prepared outside the body in the usual fashion with a nbca glue dilution of 1:3 with lipiodol and tantalum powder.The sl-10 microcatheter was primed with d5w prior.Approximately 1 cc of nbca glue dilution was introduced and injected through the sl-10 into the right mma distally.The right mma was immediately embolized.Then the sl-10 catheter was attempted to be retrieved back, but it was determined that the distal end if the catheter was attached to the right mma also.Several attempts were made to retrieve the sl-10, but the distal portion of the catheter detached.The remainder of the catheter was able to be removed from the circulation and from the body in its entirety.A goose neck snare was attempted to grab the remainder of the catheter, but that was unsuccessful.After further review (secondary opinion provided by another md), it was determined that the patient would likely be able to tolerate the remainder portion of the attached microcatheter laying over the right external and common arteries safely.The patient overall appeared to tolerate the procedure well without any other evidence of intraoperative complications.Manufacturer response for catheter, percutaneous, excelsior sl-10 (per site reporter).Ccl manager spoke with field representative.

• Brand Name: EXCELSIOR SL-10
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 20395766
• Report Number: 20395766
• Device Sequence Number: 20437028
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)250529(10)24348364
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024
• Report Date (Section F): 07/03/2024

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 Model Number: M0031681900
• Device Catalogue Number: 168190
• Device Lot Number: 24348364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Date Report Sent to FDA: 07/03/2024