PROSTAR
Report
- Report Number
- 2024168-2024-09856
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- July 28, 2024
- Report Date
- October 21, 2024
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- UDI-DI
- 08717648013102
- PMA / PMN Number
- P960043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO MALFUNCTION OR ADVERSE EVENT THAT OCCURRED, AND THIS EVENT WAS FILED IN ERROR. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H6 CORRECTION: MEDICAL DEVICE PROBLEM CODE 2610 REMOVED AND 3189 ADDED. HEALTH EFFECT - IMPACT CODE 4641 REMOVED AND 2199 ADDED.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3 - DATE OF EVENT: ESTIMATED. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.
IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED ACCESS SITE USING PROSTAR DEVICES RELATIVE TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WITH EACH DEVICE, IT WAS NOT POSSIBLE TO RETRIEVE THE NEEDLES FROM THE BARREL [NEEDLES NOT PRESENT IN BARREL AFTER DEPLOYMENT]. HEMOSTASIS WAS ACHIEVED WITH A NEW PROSTAR DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. REPORTEDLY, THE PROSTAR NEEDLES WERE DEPLOYED YET IT WAS NOT POSSIBLE TO RETRIEVE THE NEEDLES FROM THE BARREL. ANOTHER PROSTAR WAS SUCCESSFULLY DEPLOYED. THE SHEATH WAS UPSIZED TO 12F, AND THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED 10F PROSTAR SUTURES. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, ONLY THE FIRST PROSTAR DEVICE REFERENCED BELOW HAD AN ISSUE (PREVIOUSLY REPORTED UNDER EMDR-132172, EMDR-132172). THE DEVICE FOR THIS COMPLAINT WOULD NOT HAVE BEEN REPORTABLE BASED ON THE ADDITIONAL INFORMATION RECEIVED; HOWEVER, SINCE THE INITIAL REPORT HAS ALREADY BEEN FILED, THE REPORT MUST REMAIN REPORTABLE.
IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED ACCESS SITE USING PROSTAR DEVICES RELATIVE TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WITH EACH DEVICE, IT WAS NOT POSSIBLE TO RETRIEVE THE NEEDLES FROM THE BARREL [NEEDLES NOT PRESENT IN BARREL AFTER DEPLOYMENT]. HEMOSTASIS WAS ACHIEVED WITH A NEW PROSTAR DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DATE OF EVENT WILL BE ESTIMATED AS 7/28/2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 968630 | PROSTAR | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR INC. | 12322-02 | 3122041 | 08717648013102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |