MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Catalog Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the subject microcatheter was returned with the flow diverter stent device.The microcatheter shaft was severely damaged and stretched 151cm from the proximal end.The microcatheter shaft was torn and fractured with the coils pulled.The microcatheter broken/fractured tip and microcatheter coils were wrapped around the flow diverter stent delivery wire (sdw).The microcatheter hub was found to be intact.It was not possible to remove the sdw from the subject microcatheter due to the microcatheter damage.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 could not be confirmed during analysis as the device problem is unknown/unclear.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be moderately tortuous.The flow diverter was recaptured back into the microcatheter.There was no resistance between the delivery catheter and the pusher.There was no resistance encountered during navigation of the flow diverter device to the target lesion.There was no resistance during advancement of the stent delivery system through the patient¿s anatomy and there was no resistance encountered during the implant (stent) deployment.There was high % stenosis proximal to the stent likely contributing to the inability to deploy the stent.After removal, the physician attempted to deploy the stent on the table (outside the body).Product analysis found the subject microcatheter was returned with the flow diverter stent device.The microcatheter shaft was severely damaged and stretched 151cm from the proximal end.The microcatheter shaft was torn and fractured with the coils pulled and the microcatheter broken/fractured tip and microcatheter coils were wrapped around the flow diverter sdw.It was not possible to remove the sdw from the microcatheter due to the microcatheter damage.It should be noted the operator was able to withdraw the stent and re-locate it again therefore the microcatheter was functioning as intended up to this point.However, the damage to the mid to distal section of the microcatheter shaft indicates the device encountered a significant force during use which may have been due to the high % stenosis or the patient¿s moderately tortuous anatomy.An assignable cause of undeterminable was assigned for the reported event ¿device problem unknown/unclear¿ as the device problem is unknown/unclear.An assignable cause of procedural factors will be assigned to the analyzed events: ¿catheter shaft broken/fractured during use¿, ¿catheter shaft damaged¿, ¿catheter shaft stretched¿, 'catheter jammed¿ and ¿catheter tip broken/fractured during use¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject catheter was returned for analysis and the device investigation revealed that the catheter shaft was broken/fractured during use and catheter tip was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 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: 19942873
• Report Number: 3008881809-2024-00361
• Device Sequence Number: 7414153
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113778
• 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): 08/08/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 24457055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: SURPASS EVOLVE STENT (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian