STARCLOSE SE VASCULAR CLOSURE SYSTEM
Report
- Report Number
- 2953144-2010-02809
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 22, 2010
- Manufacturer
- ABBOTT VASCULAR-REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P050007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE CLIP REMAINED ON THE CLIP DELIVERY TUBESET, CONSISTENT WITH THE REPORTED EXPERIENCE. THE PROXIMAL END OF THE FLEX-GUIDE WAS HEAVILY CARVED BY THE CLIP DELIVERY TUBESET. THE CARVING BEGAN WHEN THE PLUNGER WAS DEPRESSED TO DEPLOY THE LOCATOR WINGS AND INITIATE THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING. THIS RESULTED IN THE LEAVES OF THE GARAGE TUBE TO BE BENT THAT PUNCTURED INTO THE FLEX-GUIDE AND THE EXCHANGE SHEATH, WHICH SUBSEQUENTLY, STOPPED THE EXCHANGE SHEATH SPLITTING AND THUMB ADVANCER DEPLOYMENT. MOREOVER, AN INTERNAL OBSERVATION FOUND THAT THE CARVING CAUSED A COMPLETE DETACHMENT OF THE PROXIMAL END OF THE FLEX-GUIDE. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE MECHANISM WAS ACTIVATED IN AN ATTEMPT TO COLLAPSE THE LOCATOR WINGS TO SAFELY REMOVE THE DEVICE FROM THE PATIENT ANATOMY; HOWEVER, THE CONTROL WIRE OF THE LOCATOR WINGS WAS BENT, BY THE CARVING OF THE FLEX-GUIDE, PREVENTING THEM FROM COLLAPSING INTO THE CLIP DELIVERY TUBESET. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE CARVED AND SUBSEQUENTLY DETACHED FLEX-GUIDE IS A FAILURE TO MAINTAIN ALIGNMENT BETWEEN THE TUBESET AND FLEX-GUIDE WHEN DEPRESSING THE PLUNGER TO INITIATE THE THUMB ADVANCER DEPLOYMENT, CAUSING THE TUBESET TO CARVE INTO THE FLEX-GUIDE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.
(B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.
DURING A FOLLOW-UP CALL TO A HOME PATIENT (HP) REGARDING STARTING OVER WITH NEW SUPPLIES DUE TO A SYSTEM ERROR 2201, THE HP REPORTED THAT SHE CHANGED OUT THE SUPPLIES AND THE HOME CHOICE (HC) ALARMED AGAIN. THE PATIENT STATED SHE COMPLETED THERAPY USING MANUAL SUPPLIES; HOWEVER, SHE WAS STRESSED OUT ABOUT THE ALARMS WHICH RESULTED IN A HEART ATTACK. REPORTEDLY, THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. THE PATIENT INDICATED THAT SHE HAD THE HOMECHOICE DEVICE SWAPPED AND THE NEW DEVICE WAS WORKING PERFECTLY. DURING A FOLLOW UP CALL TO THE FACILITY NURSE ON (B)(6) 2010 , THE NURSE STATED THAT THE HP WAS DIAGNOSED WITH TAKOTSUBO CARDIOMYOPATHY. THE NURSE RELATED THAT THE HUSBAND HAD TOLD THEM THAT THE ALARMS THE PATIENT HAD ON HER HOMECHOICE HAD KEPT HER AWAKE AT NIGHT AND SHE HAD LITTLE SLEEP. THE NURSE STATED THAT THE PATIENT AND HER HUSBAND FEEL THAT THE DEVICE CAUSED THE PATIENT TO HAVE A HEART ATTACK.
IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE PLUNGER, THUMB ADVANCER DEPLOYMENT COULD NOT BE STARTED. THE SAFETY RELEASE WAS ACTIVATED, WHICH SUCCESSFULLY RELEASED THE DEVICE FROM THE PT ANATOMY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE SE VASCULAR CLOSURE SYSTEM | IMPLANTABLE CLIP | MGB | ABBOTT VASCULAR-REDWOOD CITY | NA | 890236H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |