MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-17 FLEX STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Model Number	M003C1715ST0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report prefers to excelsior xt-17 flex straight 150cm.(this is 2 of 2 reports) the subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during stent implantation aneurysm embolization case, a big resistance was encountered when delivering the stent through the microcatheter (subject device) and the stent was hard to be advanced.Finally, when it reached to the tip of the subject microcatheter, the resistance became bigger and only the tip of the stent could be deployed.Therefore, the stent and the subject microcatheter were withdrawn together.It was observed that the segment at the subject microcatheter near the tail of the stent was fractured.The stent and subject microcatheter were replaced with other products to complete the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject catheter was returned with an atlas stent device.During analysis, the catheter shaft was seen to be broken and kinked from the catheter tip.The catheter tip was seen to be flatted and the catheter distal shaft stretched.On advancing the mandrel through the catheter, strong resistance was met.The catheter hub was seen to have burrs which were within interim specification.The reported complaint was confirmed based on analysis of the returned product.The subject catheter device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 provided by the customer indicated that the subject catheter device was prepared for use as per the directions for use and no damage was 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.Also, continuous flush was set up and maintained throughout the clinical procedure.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 the as reported codes: 'catheter shaft broken/fractured during use' and 'catheter friction' and as analyzed codes: 'catheter shaft kinked/bent', 'catheter shaft broken/fractured during use', 'catheter tip flat/crushed', 'catheter shaft stretched' and 'catheter friction' will be assigned procedural factors.
Event or Problem Description
It was reported that during stent implantation aneurysm embolization case, a big resistance was encountered when delivering the stent through the microcatheter (subject device) and the stent was hard to be advanced.Finally, when it reached to the tip of the subject microcatheter, the resistance became bigger and only the tip of the stent could be deployed.Therefore, the stent and the subject microcatheter were withdrawn together.It was observed that the segment at the subject microcatheter near the tail of the stent was fractured.The stent and subject microcatheter were replaced with other products to complete the procedure without clinical consequences to the patient.

• Brand Name: EXCELSIOR XT-17 FLEX 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: 16448923
• Report Number: 3008881809-2023-00092
• Device Sequence Number: 17496913
• Product Code: DQY
• UDI-Device Identifier: 07613252714903
• UDI-Public: 07613252714903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142565
• 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): 05/15/2023

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: 08/21/2024
• Device Model Number: M003C1715ST0
• Device Catalogue Number: M003C1715ST0
• Device Lot Number: 23821098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON10 MICROCATHETER; GUIDING CATHETER ( ENVOY DA); NEUROFORM ATLAS STENT (STRYKER)
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Race: Asian