PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Report
- Report Number
- 2024168-2023-11729
- Event Type
- Injury
- Date Received
- October 23, 2023
- Date of Event
- September 29, 2023
- Report Date
- December 6, 2023
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- UDI-DI
- 28717648013083
- PMA / PMN Number
- P960043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULT TO REMOVE COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. REPORTEDLY, THE DEVICE HAD TROUBLE WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT ANATOMY AND USED FORCE TO REMOVE IT. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (EIFU), STATES: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. IT¿S UNLIKELY THE EIFU VIOLATION CONTRIBUTED TO THE REPORTED DIFFICULTY. THE REPORTED PATIENT EFFECTS OF HEMORRHAGE/BLEEDING AND VASCULAR DISSECTION ARE LISTED IN THE ELECTRONIC PERCLOSE PROGLIDE INSTRUCTIONS FOR USE (EIFU), AS POTENTIAL ADVERSE EVENTS OF USE OF THE DEVICE. THE ROOT CAUSE OF THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THE SUBSEQUENT TREATMENTS ARE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS POSSIBLE, THE PLUNGER WAS PULLED (STEP 3) PRIOR TO DEPLOYMENT OF THE NEEDLES (STEP 2) BASED ON THE POSTERIOR NEEDLE TIP INSIDE THE GUIDE TUBE. ADDITIONALLY, THE NEEDLE HAD NO INDICATION OF CONTACT WITH THE CUFF WHICH MAY ALSO INDICATE A CUFF MISS. A MANUFACTURING ISSUE IS POSSIBLE, HOWEVER, WITHOUT THE PLUNGER THIS CANNOT BE CONFIRMED. THERE WAS NO INDICATION OF ISSUES WITH DIFFICULTY TO CLOSE THE FOOT, WHICH WOULD ACCOUNT FOR THE TISSUE DAMAGE DURING REMOVAL. SO, IT MAY ALSO BE THE SUTURE WAS CAUGHT ON THE FOOT WHICH COULD CONTRIBUTE TO THE DIFFICULTY TO REMOVE THE PLUNGER AND THE DEVICE. THE OBESITY OF THE PATIENT IS ALSO A FACTOR. THE PLUNGER AND LINK WERE ALSO NOT RETURNED TO CONFIRM. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL PERCLOSE PROSTYLE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ATTACHMENT: MEDWATCH REPORT #MW5146958.D4: LOT# UPDATED FROM 2120341 TO 2082541. H6: HEALTH EFFECT-IMPACT CODE 4559 REMOVED AND 3160 ADDED.
H6: MEDICAL DEVICE PROBLEM CODE 2017 ¿ FAILURE TO FOLLOW STEPS/INSTRUCTIONS. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
H6: MEDICAL DEVICE PROBLEM CODE 2017 ¿ FAILURE TO FOLLOW STEPS/INSTRUCTIONS. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION AND USER FACILITY MEDWATCH REPORT #MW5146958 WERE RECEIVED: REPORTEDLY, TWO PROGLIDE DEVICES WERE USED AND HAD A DEVICE ISSUE. ONE DEVICE ISSUE WAS UNSPECIFIED. THE KNOT OF THE SECOND PROGLIDE WAS ENTANGLED IN THE DEVICE AND COULD NOT BE HARVESTED. A THIRD PROGLIDE WAS OPENED WITH THE PLUNGER FALLING OFF WHEN OPENING; THE DEVICE WAS NOT USED. (MW5146958) STATED: ABBOTT VASCULAR PERCLOSE PROGLIDE MISFIRED. THE SUTURE GOT CAUGHT IN THE DEVICE AND WOULD NOT COME OFF THE DEVICE. WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE VESSEL, IT TORE A LARGER HOLE IN THE VESSEL REQUIRING A REPAIR OF THE RIGHT FEMORAL ARTERY. A SECOND ABBOTT VASCULAR PERCLOSE PROGLIDE FELL APART AT THE HANDLE WHEN REMOVED FROM THE PACKAGE NEVER REACHED THE PATIENT. WE HAVE THE LOT NUMBERS OF BOTH DEVICES BUT ARE UNABLE TO IDENTIFY WHICH WAS USED ON THE PATIENT. THE PT WAS OBESE, THE VESSEL WAS DEEP AND TORTUOUS; (17) 241031 (10) 2120341 (91) 3798, CANNOT CONFIRM THIS WAS THE DEVICE THAT MISFIRED, THERE WERE ISSUES WITH 2 DEVICES. REFERENCE REPORT[S]: MW5146958. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THIS WAS A VENOUS CLOSURE OF A COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A VASCULAR INTERVENTIONAL PROCEDURE. REPORTEDLY, THE KNOT OF THE FIRST PROGLIDE WAS ENTANGLED IN THE DEVICE AND COULD NOT BE HARVESTED. THERE WAS RESISTANCE ON REMOVAL; A DISSECTION WAS NOTED. BLOOD LOSS WAS OBSERVED. THE SHEATH WAS UPSIZED TO 10F TO CONTROL BLEEDING. ANOTHER PROGLIDE WAS OPENED WITH THE PLUNGER FALLING OFF WHEN OPENING; THE DEVICE WAS NOT USED. IT WAS DECIDED TO ABANDONED THE PROCEDURE. HEMOSTASIS WAS ACHIEVED WITH MANUAL SUTURING. THERE WAS A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THIS WAS A VENOUS CLOSURE OF A COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A VASCULAR INTERVENTIONAL PROCEDURE. REPORTEDLY, THE KNOT OF THE FIRST PROGLIDE WAS ENTANGLED IN THE DEVICE AND COULD NOT BE HARVESTED. THERE WAS RESISTANCE ON REMOVAL; A DISSECTION WAS NOTED. BLOOD LOSS WAS OBSERVED. THE SHEATH WAS UPSIZED TO 10F TO CONTROL BLEEDING. ANOTHER PROGLIDE WAS OPENED WITH THE PLUNGER FALLING OFF WHEN OPENING; THE DEVICE WAS NOT USED. IT WAS DECIDED TO ABANDONED THE PROCEDURE. HEMOSTASIS WAS ACHIEVED WITH MANUAL SUTURING. THERE WAS A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1981406 | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM | SUTURE MEDIATED CLOSURE | MGB | ABBOTT VASCULAR | 2082541 | 28717648013083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |