MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - US; CATHETER, PERCUTANEOUS

Model Number M003IC0601320

Device Problem Fracture (1260)

Patient Problems Death (1802); Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2020

Event Type  Death  

Manufacturer Narrative

Device not received for evaluation.

Event Description

It was reported that during the procedure for a thrombectomy for l m1 occlusion, the tip of a catheter (subject device) broke inside the patient¿s anatomy.The physician used a thrombectomy device and balloon corking technique to remove the broken fragment.The physician was unsuccessful to remove the broken fragment and it remains inside the patient¿s anatomy.There was surgical delay and it was reported that the patient has passed away.No further information is available.

Event Description

It was reported that during the procedure for a thrombectomy for l m1 occlusion, the tip of a catheter (subject device) broke inside the patient¿s anatomy.The physician used a thrombectomy device and balloon corking technique to remove the broken fragment.The physician was unsuccessful to remove the broken fragment and it remains inside the patient¿s anatomy.There was surgical delay and it was reported that the patient has passed away.No further information is available.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint was unable to be confirmed and it cannot be confirmed if the device met specifications as it was not returned for analysis.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was not returned for analysis.It cannot be determined from the available information what caused the catheter tip/ro marker to break/ fracture, therefore an assignable cause of undeterminable will be assigned to the reported catheter tip broken/fractured event.Patient death is listed in the dfu as a potential adverse event associated with the use of the device, however it cannot be definitively determined if the device malfunction caused or contributed to the patient death, therefore an assignable cause of undeterminable will be assigned to the reported patient death.H3 other text : device not received for evaluation.

• Brand Name: AXS CATALYST 6 .060IN ID X 132CM - US
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10273842
• MDR Text Key: 198840693
• Report Number: 3008881809-2020-00204
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 07613327012033
• UDI-Public: 07613327012033
• Combination Product (y/n): N
• PMA/PMN Number: K183463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M003IC0601320
• Device Catalogue Number: M003IC0601320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN STENT RETRIEVER (UNKNOWN); UNKNOWN THROMBECTOMY DEVICE (UNKNOWN)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 75