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

Catalog Number	M003XT2750810
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
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 there was damage (scrape) to the catheter shaft.There were no other anomalies noted.During the functional inspection the device was flushed and a leak was identified.The leak was coming from beneath the strain relief.The strain relief was removed, and the device was flushed again.The leak was coming from damaged part of the catheter shaft.There was no damage to the strain relief.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.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use and the dispenser hoop was flushed before removing the catheter, no resistance was encountered removing the catheter from the dispenser hoop and there was no damage noted to the packaging prior to opening the packaging.Also additional information provided indicated saline was escaping whilst flushing.It was never used or inserted into patient.During analysis the returned catheter was flushed and a leak was coming from beneath the primary strain relief.To determine where the leak was coming from - the primary strain relief was removed to allow a visual examination of the proximal shaft.There was a scrape visible on the complaint unit.The quality/ engineering line support for the catheter viewed the unit and confirmed the issue.The catheter hub was intact.The physician may have perceived the hub to be leaking rather than the catheter shaft due to the location of the leak.An assignable cause of manufacturing will be assigned to the reported event of a catheter hub leak and catheter damaged as well as the as analyzed damage of the catheter shaft leak during preparation and catheter shaft has hole/perforation as this is an issue in which product fails to meet specification due to the manufacturing process at a stryker neurovascular manufacturing site.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the catheter (subject device) shaft had a hole.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: 19397209
• Report Number: 3008881809-2024-00232
• Device Sequence Number: 20569478
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 01/31/2025
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 23456105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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
• Patient Sex: Unknown