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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 125CM - CE; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 125CM - CE; CATHETER, THROMBUS RETRIEVER Back to Search Results
Catalog Number INC-11989-125
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2023
Event Type  malfunction  
Event Description
It was reported that the procedure, the catheter (subject device) fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H3 other text: the device is not available to the manufacturer.
 
Event Description
It was reported that the procedure, the catheter (subject device) fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
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 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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported event of the catheter shaft broken/fractured during use.
 
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Brand Name
AXS VECTA 074 CATH 125CM - CE
Type of Device
CATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
STRYKER NEUROVASCULAR-CALIF
47900 bayside parkway
fremont CA 94538
Manufacturer (Section G)
STRYKER NEUROVASCULAR-CALIF
47900 bayside parkway
fremont CA 94538
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key17803034
MDR Text Key324125782
Report Number3008853977-2023-00038
Device Sequence Number1
Product Code NRY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K172167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2023
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
Device Operator Health Professional
Device Expiration Date12/07/2023
Device Catalogue NumberINC-11989-125
Device Lot Number16266-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/03/2023
Initial Date FDA Received09/22/2023
Supplement Dates Manufacturer Received10/18/2023
Supplement Dates FDA Received10/26/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SL-10 MICROCATHETER (STRYKER); TARGET COILS (STRYKER)
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