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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK AXS CATALYST 6 .060IN ID X 132CM - US CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameAXS CATALYST 6 .060IN ID X 132CM - US
Type of DeviceCATHETER, 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 Key10273842
MDR Text Key198840693
Report Number3008881809-2020-00204
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK183463
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM003IC0601320
Device Catalogue NumberM003IC0601320
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/14/2020 Patient Sequence Number: 1
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