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	05/19/2022
Type of Reportable Event	Malfunction
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.The device was received.The reported lot number was confirmed from the hub and from the packaging label.During visual inspection, the catheter shaft was found to be severely kinked/bent.The tip of the catheter was found to be damaged and broken/fractured 155 cm form the proximal end.The radio opaque (ro) marker was detached/fractured.The hub was found to be intact.Catheter difficulty advancing guidewire functional test was unable to perform due to condition of the device.Catheter tip damaged functional test was confirmed during visual inspection.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 specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient.The damage noted to the device would be indicative of the as reported defect.It was seen that the microcatheter was severely damaged, and part of the distal shaft and the ro marker was detached.The as reported events of catheter difficulty advancing guidewire and catheter tip damaged as well as the as analysed events of ro marker(s) detached/separated/not visible under fluoroscopy, catheter tip broken/fractured during use, catheter shaft kinked/bent, catheter tip damaged will be assigned procedural factors as these defects appear 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 or anatomical factors during use.
Event or Problem Description
Analysis of the returned device revealed that subject catheter tip was broken/fractured during use and radio opaque (ro) markers(s) detached/separated/not visible under fluoroscopy.There was no clinical consequence to the patient.

• 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
• 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: 15418967
• Report Number: 3008881809-2022-00449
• Device Sequence Number: 6581546
• 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
• Report Date (Section B): 09/14/2022

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: 10/10/2024
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 23249404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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: SYNCHRO2 GUIDEWIRE (STRYKER)
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Asian