PERCLOSE¿ PROSTYLE¿
Report
- Report Number
- 2024168-2024-13676
- Event Type
- Injury
- Date Received
- November 19, 2024
- Date of Event
- November 4, 2024
- Report Date
- December 21, 2024
- Manufacturer
- ABBOTT VASCULAR INC.
- 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 NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. REPORTEDLY, FEMORAL IMAGING WAS NOT PERFORMED. IT SHOULD BE NOTED THAT THE ELECTRONIC PERCLOSE PROSTYLE INSTRUCTIONS FOR USE (EIFU), STATES: PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU VIOLATION CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH CALCIFIED PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B5: DESCRIBE EVENT OR PROBLEM UPDATED. D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM ASKU TO NO. E1: FIRST, LAST NAME UPDATED FROM (B)(6). E1: TITLE UPDATED FROM MS. TO DR. E3: OCCUPATION UPDATED FROM PHARMACIST TO PHYSICIAN. G2: REPORT SOURCE ADDED COMPANY REPRESENTATIVE. H6: HEALTH EFFECT - IMPACT CODE 4641 REMOVED, 4624 ADDED. H6: MEDICAL DEVICE PROBLEM CODE 2017- FAILURE TO FOLLOW STEPS / INSTRUCTIONS - NO FEMORAL IMAGING WAS PERFORMED.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, AN ABNORMALITY WAS OBSERVED ON SEVERAL PROSTYLES FROM THE SAME LOT NUMBER: 4081841. ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. SUBSEQUENT TO THE INITIALLY FILED MDR, ADDITIONAL INFORMATION WAS OBTAINED: FEMORAL IMAGING WAS NOT PERFORMED. THERE WERE ONLY TWO PROSTYLES THAT MALFUNCTIONED, NOT THREE AS PREVIOUSLY FILED. IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A GREATER THAN 10F SHEATH HOLE PRIOR TO AN INTERVENTIONAL ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. REPORTEDLY, THE NEEDLES WERE UNABLE TO PASS THROUGH THE ARTERY DUE TO SEVERE CALCIFICATIONS. ANOTHER PROSTYLE WAS USED BUT THE SAME ISSUE OCCURRED. PRE-CLOSE WAS ABANDONED AND SURGICAL INTERVENTION WAS PERFORMED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THIS WAS A VESSEL PUNCTURE CLOSURE OF AN UNKNOWN VESSEL USING A PROSTYLE DEVICE. REPORTEDLY, AN ABNORMALITY WAS OBSERVED ON SEVERAL PROSTYLES FROM THE SAME LOT NUMBER: 4081841. ANOTHER DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND 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 |
|---|---|---|---|---|---|---|---|
| 2106023 | PERCLOSE¿ PROSTYLE¿ | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR INC. | 12773-02 | 4081841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |