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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.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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.An assignable cause of anticipated procedural complication will be assigned to the patient codes as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.The as reported unexpected movement of device and catheter hub friction will be assigned a cause of undeterminable as the device was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event.
 
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 Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key12100082
MDR Text Key259394389
Report Number3008881809-2021-00286
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K142565
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/11/2021
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? No
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/10/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received09/17/2021
Supplement Dates FDA Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NEUROFORM ATLAS STENT (STRYKER).; UNKNOWN COILS.; NEUROFORM ATLAS STENT (STRYKER); UNKNOWN COILS
Patient Outcome(s) Other; Required Intervention;
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