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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 125CM - US; CATHETER, THROMBUS RETRIEVER
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STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 125CM - US; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number INC-11129-125
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2023
Event Type  malfunction  
Event Description
It was reported that the catheter (subject device) stripped and pulled apart while removing from patient.All parts were contained and removed safely from patient.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
The device is not available to the manufacturer.
 
Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During a visual inspection, the catheter shaft was seen to be kinked between 14 and 16cm from the tip, the catheter shaft was seen to be broken 22cm form the tip, the inner coil wind was seen to be exposed thru the break and the shaft, the catheter shaft was seen to be flat/crushed between 28 and 32cm from the tip, and the catheter tip was seen to be flat/crushed.A functional inspection was not required as the break was confirmed during analysis.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The catheter was seen to be kinked and broken.The inner coil wind was seen to be exposed through the break and the shaft.The catheter shaft was seen to be flat/crushed.The catheter tip was seen to be flat/crushed.Therefore the as reported can be confirmed.An assignable cause of procedural factors will be assigned to as reported and as analyzed code, 'catheter shaft broken/fractured during use' as well as to as analyzed codes, 'catheter shaft kinked/bent', 'catheter shaft flat/crushed' and 'catheter tip flat/crushed as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
 
Event Description
It was reported that the catheter (subject device) stripped and pulled apart while removing from patient.All parts were contained and removed safely from patient.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
AXS VECTA 071 CATH 125CM - US
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 Key16632253
MDR Text Key312319622
Report Number3008853977-2023-00006
Device Sequence Number1
Product Code NRY
UDI-Device Identifier07613327459227
UDI-Public07613327459227
Combination Product (y/n)N
Reporter Country CodeUS
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 05/19/2023
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 Date09/09/2023
Device Model NumberINC-11129-125
Device Catalogue NumberINC-11129-125
Device Lot Number15745-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2023
Initial Date FDA Received03/28/2023
Supplement Dates Manufacturer Received05/10/2023
Supplement Dates FDA Received05/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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