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

Catalog Number	M003XT2750810
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
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.During visual/microscopic inspection, the catheter shaft was found to be kinked/bent in multiply areas.The catheter shaft was flat/crushed.The tip of the catheter was found to be broken/fractured.The hub was found to be intact.During functional inspection, the device was flushed.An attempt was taken to advance the patency mandrel to check the id; however, the mandrel stuck 125 cm from the proximal end and could not be advanced further due to significant friction caused by damages to the device.An attempt was taken to advance the guidewire through; however the guidewire stuck 125 cm from the proximal end of the microcatheter.The device was advanced through the demo guide catheter; however significant friction was noted.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, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.Flushed the microcatheter and delivered it but tip of it could not be advanced into middle catheter even after several tries.Also additional information received the middle catheter used in the procedure was an intermediate catheter, there was friction experienced while advancing the microcatheter within the middle catheter shaft and no device fragment was left inside the patient.It was seen that the microcatheter was flattened, kinked and the distal tip and marker had fragmented.The microcatheter distal shaft was damaged, this would have caused issues advancing through the guide catheter.An attempt to advance the microcatheter in the middle catheter was made several times in the procedure but could not be advanced which could have caused the distal tip to detach.The microcatheter most likely was damaged during the procedure due to some procedural/anatomical factors encountered during use leading to the as reported and as analyzed event.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the as reported "catheter shaft difficulty advancing" as well as the as analyzed "catheter shaft friction", "catheter shaft kinked/bent", "catheter shaft flat/crushed", "catheter tip broken/fractured during use", "catheter shaft difficulty advancing" and "catheter difficulty advancing guidewire".
Event or Problem Description
Analysis of the returned device found that the subject catheter tip was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• 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: 18166597
• Report Number: 3008881809-2023-00557
• Device Sequence Number: 6466528
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• 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): 11/18/2023

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: 07/12/2023
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 22336592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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: AXS CATALYST 5 INTERMEDIATE CATHETER (STRYKER).; EXCELSIOR XT 17 MICROCATHETER (STRYKER).; NEUROFORM EZ STENT (STRYKER).; SYNCHRO2 GUIDEWIRE (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian