AXS VECTA 074 CATH 132CM - CE
Report
- Report Number
- 3008853977-2024-00023
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- July 11, 2024
- Report Date
- October 15, 2024
- Manufacturer
- STRYKER NEUROVASCULAR-CALIF
- Product Code
- QJP
- UDI-DI
- 07613327461787
- PMA / PMN Number
- K200206
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS 1 OF 2 REPORTS.
D2A COMMON DEVICE NAME- CORRECTED TO CATHETER, PERCUTANEOUS, NEUROVASCULATURE. D2B PRODUCT CODE: CORRECTED TO QJP. D4 GTIN: CORRECTED TO (B)(4). D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER/ RETURNED TO MANUFACTURER ON ¿UPDATED. G4 PMA/510(K) ¿ CORRECTED TO K200206. H3 DEVICE EVALUATED BY MFG ¿ UPDATED. H4 MANUFACTURING DATE ¿ ADDED. BASED ON THE RESULTS OF THE DHR (DEVICE HISTORY RECORD REVIEW) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. VISUAL/MICROSCOPIC INSPECTION REVEALED THAT SUBJECT CATHETER WAS RETURNED AND STUCK INSIDE THE INFINITY CATHETER AND COULD NOT BE REMOVED. ADDITIONALLY, AN UNKNOWN GUIDEWIRE WAS STUCK INSIDE THE SUBJECT CATHETER AND INFINITY CATHETER. THE SUBJECT CATHETER SHAFT WAS NOTED TO BE BROKEN FRACTURED 119CM FROM THE HUB. THE DISTAL CATHETER SHAFT WAS NOTED TO BE STRETCHED AND THE CATHETER TIP WAS NOTED TO BE DAMAGED. THE RETURNED INFINITY CATHETER WAS INITIALLY INTACT, BUT IT WAS DAMAGED DURING THE COMPLAINT INVESTIGATION A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DAMAGE TO THE SUBJECT CATHETER DEVICE. THE REPORTED ¿CATHETER SHAFT BROKEN/FRACTURED DURING USE¿ AND ¿CATHETER SHAFT DEFORMED¿ WERE CONFIRMED DURING ANALYSIS. THE ¿CATHETER FRICTION¿ COULD NOT BE DUPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. ¿PATIENT VASOSPASM NON-SERIOUS¿ COULD NOT BE CONFIRMED AS THE EVENT IS PROCEDURE/PATIENT RELATED. THE SUBJECT CATHETER DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. 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 SUBJECT CATHETER WAS RETURNED STUCK INSIDE THE INFINITY CATHETER AND COULD NOT BE REMOVED. ADDITIONALLY, AN UNKNOWN GUIDEWIRE WAS STUCK INSIDE THE SUBJECT CATHETER AND INFINITY CATHETER. THE SUBJECT CATHETER SHAFT WAS NOTED TO BE BROKEN FRACTURED 119CM FROM THE HUB. THE DISTAL SUBJECT CATHETER SHAFT WAS NOTED TO BE STRETCHED AND DAMAGED. THE RETURNED INFINITY CATHETER WAS INITIALLY INTACT, BUT IT WAS DAMAGED DURING THE COMPLAINT INVESTIGATION. THE ADDITIONAL INFORMATION MENTIONS THAT ANATOMY OF THE PATIENT WAS VERY TORTUOUS, AND IT IS LIKELY THAT VERY TORTUOUS ANATOMY OF THE PATIENT LED THE RESISTANCE INITIALLY FELT DURING INSERTING THE SUBJECT CATHETER AND EXCESSIVE FORCE APPLIED TO REMOVE THE SUBJECT CATHETER LED THE FRACTURE OF THE SUBJECT CATHETER SHAFT. AN ASSIGNABLE CAUSE ¿PROCEDURAL FACTORS ¿ WILL BE ASSIGNED TO THE REPORTED ¿CATHETER SHAFT BROKEN/FRACTURED DURING USE¿, ¿CATHETER FRICTION¿, ¿CATHETER SHAFT DEFORMED¿ AS WELL AS THE ANALYZED ¿CATHETER JAMMED¿, ¿CATHETER SHAFT STRETCHED¿ AND ¿CATHETER TIP DAMAGED¿ 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. AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE REPORTED ¿PATIENT VASOSPASM NON-SERIOUS¿, 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.
IT WAS REPORTED THAT DURING INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY, THE SUBJECT DEVICE WAS USED WITH OTHER DEVICES IN THE VESSEL AND TORTUOUS AORTIC ARCH AS THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE SUBJECT DEVICE. THEREFORE, THE SUBJECT DEVICE WAS WITHDRAWN, AS THE OUTER PART OF THE SUBJECT DEVICE WAS PEELED OFF AND SNAPPED OFF. THE SNARE WAS USED TO RETRIEVE THE FRACTURED FRAGMENT PARTS AND COMPLETED THE PROCEDURE. THE DISTAL PART OF THE SUBJECT DEVICE WAS OBSERVED TO BE NARROWING. NO OTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT DURING INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY, THE SUBJECT DEVICE WAS USED WITH OTHER DEVICES IN THE VESSEL AND TORTUOUS AORTIC ARCH AS THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE SUBJECT DEVICE. THEREFORE, THE SUBJECT DEVICE WAS WITHDRAWN, AS THE OUTER PART OF THE SUBJECT DEVICE WAS PEELED OFF AND SNAPPED OFF. THE SNARE WAS USED TO RETRIEVE THE FRACTURED FRAGMENT PARTS AND COMPLETED THE PROCEDURE. THE DISTAL PART OF THE SUBJECT DEVICE WAS OBSERVED TO BE NARROWING. NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370680 | AXS VECTA 074 CATH 132CM - CE | CATHETER, PERCUTANEOUS, NEUROVASCULATURE | QJP | STRYKER NEUROVASCULAR-CALIF | 18930-01 | 07613327461787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | INFINITY CATHETER (STRYKER)| SNARE DEVICE| SYNCHRO GUIDEWIRE (STRYKER) |