MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M0031681900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The subject catheter was returned for analysis and the device investigation revealed that the subject catheter shaft was broken/fractured during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the catheter distal shaft was seen to be kinked/bent.The catheter distal shaft was seen to be cut at 147.5 cm from the hub.The catheter hub was intact.The catheter tip was not returned.During the functional inspection, the catheter was flushed, and a 0.0158" patency mandrel was advanced through the microcatheter.Resistance was noted in the distal shaft, and the concomitant coil was pushed out.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 reported complaint was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while delivering the coil, the operator tried to resheath the coil, then redelivered the coil into the catheter and the coil detached whilst in the catheter.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.The continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis, and it was noted that the catheter distal shaft was seen to be kinked/bent.The catheter distal shaft was seen to be cut at 145.5 cm from the hub.The catheter hub was intact.The catheter tip was not returned.On functional inspection, the catheter was flushed and a patency mandrel was advanced through the microcatheter.Resistance was noted in the distal shaft, and the concomitant coil was pushed out of catheter.The reported events 'catheter, difficulty advancing coil' and 'catheter, coil jammed' were confirmed.The reported event 'catheter, coil jammed' will be assigned a probable cause of procedural factors and the reported and analyzed 'catheter, difficulty advancing coil' will be assigned a probable cause of procedural factors.The analysed 'catheter shaft kinked/bent', 'catheter shaft friction', and 'catheter shaft broken/fractured during use' will be assigned a probable cause of procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 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: 21098297
• Report Number: 3008881809-2025-00019
• Device Sequence Number: 12944683
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: (01)04546540688224(17)251016(10)24585195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/07/2025

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: 10/16/2025
• Device Catalogue Number: M0031681900
• Device Lot Number: 24585195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: TARGET COIL (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White