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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)
Event Date 06/09/2021
Event Type  Injury  
Manufacturer Narrative

Device is not available to manufacturer.

 
Event Description

It was reported that during the procedure, the position of microcatheter (subject device) was displaced. During an attempt of aligning deployment position, aca was torn by the subject microcatheter and bleeding occurred during the procedure. Additional stent and coils were used as medical intervention to stop the bleeding. The patient's anatomy was reported to be very tortuous. It was reported that the bleeding was stopped and the torn aca was treated successfully. The procedure was completed successfully. No clinical consequences were reported to the patient due to this event.

 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
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 Key12100082
MDR Text Key259394389
Report Number3008881809-2021-00286
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK142565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_NEU
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 Received06/10/2021
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: 07/01/2021 Patient Sequence Number: 1
Treatment
NEUROFORM ATLAS STENT (STRYKER); UNKNOWN COILS
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