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	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The microcatheter was returned for analysis and it was discovered that the catheter shaft was broken/fractured during use.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 catheter was found to be broken off the hub, the catheter shaft was found to be kinked/bent in multiply areas, the tip and the hub were found to be intact.During functional inspection catheter shaft friction functional test was not performed due to visual defect noted.An attempt was taken to remove the sdw (stent delivery wire) from the catheter; however, it was not possible.The catheter was cut to remove the sdw (stent delivery wire).An attempt was taken to advance the patency mandrel to measure the id.It was difficult to flush the device, significant resistance was noted.The mandrel stuck 49 cm from proximal end and 9 cm from the distal end due to dry blood 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.Also, additional information received indicated that patient anatomy was severely tortuous which would have contributed to the event.It was seen that the microcatheter was kinked which would have caused difficulty advancing the stent during the procedure.The microcatheter shaft most likely broke trying the advance/retract the stent during the procedure.The catheter was most likely damaged during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analyzed defects.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the as reported.

• 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: 16287425
• Report Number: 3008881809-2023-00051
• Device Sequence Number: 6700996
• 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): 02/02/2023

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: 11/03/2024
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 23308264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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: EXCELSIOR SL-10 MICROCATHETER(STRYKER); NEUROFORM EZ STENT (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: Asian