PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Report
- Report Number
- 2024168-2023-09302
- Event Type
- Injury
- Date Received
- August 25, 2023
- Date of Event
- August 1, 2023
- Report Date
- October 25, 2023
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- PMA / PMN Number
- P960043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE RETRIEVAL ISSUE WAS CONFIRMED AS A LINK SEPARATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY, LINK PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.D4: LOT NUMBER UPDATED FROM 3022241 TO 3022741 H6: MEDICAL DEVICE PROBLEM CODE 2616 WAS REMOVED AND 1142 WAS ADDED.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PROGLIDE DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
IT WAS REPORTED THAT BILATERAL SUTURE PLACEMENT IN TWO DIFFERENT ACCESS SITES WAS ATTEMPTED WITH TEN PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN UNSPECIFIED NUMBER OF PROGLIDE DEVICES HAD THE SUTURE NOT STAY IN PLACE AFTER RETRIEVAL AND THE SUTURE DID NOT CLOSE IN ONE OF THE ACCESS SITES AND AN UNSPECIFIED NUMBER HAD THE SAME ISSUE IN THE OTHER ACCESS SITE. THE SUTURES OF TWO NEW PROGLIDES DEVICES WERE SUCCESSFULLY PRE-PLACED IN EACH OF THE ACCESS SITES. THE INTERVENTIONAL PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES AT BOTH ACCESS SITES. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, ADDITIONAL INFORMATION WAS OBTAINED BY THE ACCOUNT: THE TWO ACCESS SITES WERE THE RIGHT COMMON FEMORAL ARTERY AND THE LEFT COMMON FEMORAL ARTERY. THE INTERVENTIONAL PROCEDURE WAS AN ABDOMINAL AORTIC ANEURYSM (AAA). FIVE PROGLIDES FAILED IN EACH ACCESS SITE. THE INITIAL SHEATH SIZE USED WAS 7F FOR EACH ACCESS SITE. THE MAXIMUM SHEATH SIZE USED WAS 10F FOR EACH ACCESS SITE. ADDITIONALLY, IT WAS ALSO CLARIFIED THAT WHAT OCCURRED WAS WHEN THE PLUNGER WAS REMOVED, NO SUTURE WAS ATTACHED/PRESENT AND NOT THAT THE SUTURE DID NOT STAY IN PLACE AFTER RETRIEVAL AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT BILATERAL SUTURE PLACEMENT IN TWO DIFFERENT ACCESS SITES WAS ATTEMPTED WITH TEN PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN UNSPECIFIED NUMBER OF PROGLIDE DEVICES HAD THE SUTURE NOT STAY IN PLACE AFTER RETRIEVAL AND THE SUTURE DID NOT CLOSE IN ONE OF THE ACCESS SITES AND AN UNSPECIFIED NUMBER HAD THE SAME ISSUE IN THE OTHER ACCESS SITE. THE SUTURES OF TWO NEW PROGLIDES DEVICES WERE SUCCESSFULLY PRE-PLACED IN EACH OF THE ACCESS SITES. THE INTERVENTIONAL PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES AT BOTH ACCESS SITES. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 889854 | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM | SUTURE MEDIATED CLOSURE | MGB | ABBOTT VASCULAR | 3022741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |