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

Model Number	M003XT2750910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure while being placed and adjusted, the catheter (subject device) tail was fractured.The physician replaced the subject device and completed the procedure without clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the device was returned together with transcend.The catheter shaft was found to be flatten/crushed.The distal shaft was found to be deformed.The catheter hub was found to be broken/fractured from catheter shaft.Functional inspection: not required.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 received from the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush set up was maintained throughout the clinical procedure.The catheter hub was in fact seen to be broken/fractured which may have been perceived by the physician that the shaft was fractured.Therefore, the as reported cannot be confirmed.The as reported catheter shaft broken/fractured during use will be given an assignable cause of not confirmed.The as analyzed catheter shaft deformed, catheter shaft flat/crushed and catheter hub broken/fractured will be assigned procedural factors as this complaint appears 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 factors during use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure while being placed and adjusted, the catheter (subject device) tail was fractured.The physician replaced the subject device and completed the procedure without clinical consequences to the patient due to this event.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11971438
• Report Number: 3008881809-2021-00240
• Device Sequence Number: 1153384
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• 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,Followup
• Report Date (Section B): 08/19/2021

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: 03/03/2023
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 22178380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1