MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 - 060X132 (FDA); CATHETER, PERCUTANEOUS

Model Number M003IC0601320

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Event Description

It was reported that the intermediate catheter(subject device) was torn at the middle shaft part and there was leakage noted during use as well.The catheter was removed from patient's anatomy and replaced with another catheter.The procedure was completed successfully with no reported clinical consequences to the patient.

Event Description

It was reported that the intermediate catheter(subject device) was torn at the middle shaft part and there was leakage noted during use as well.The catheter was removed from patient's anatomy and replaced with another catheter.The procedure was completed successfully with no reported clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device history record confirms that the device met all material, assembly and performance specifications.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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.Visual inspection of the device revealed that the proximal end of the catheter was kinked with a hole/ perforation from the distal end.During functional testing, the device was flushed, and it was noted to be leaking through the hole and a patency mandrel passed without difficulty.The reported event of hole in the catheter and leak was able to be confirmed based on analysis of the device.It is probable that the device was damaged during the clinical procedure due to procedural factors experienced during use of the device.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the investigation.

• Brand Name: AXS CATALYST 6 - 060X132 (FDA)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9485468
• MDR Text Key: 176102978
• Report Number: 3008881809-2019-00397
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: 07613327012033
• Combination Product (y/n): N
• PMA/PMN Number: K151667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: M003IC0601320
• Device Catalogue Number: M003IC0601320
• Device Lot Number: 21319705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTIMO 8FGUIDING CATHETER(TOKAI)