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

Model Number	M003IC0601320
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2019
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9485468
• Report Number: 3008881809-2019-00397
• Device Sequence Number: 16644698
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: 07613327012033
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K151667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 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
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPTIMO 8FGUIDING CATHETER(TOKAI)