PERCLOSE PROGLIDE¿
Report
- Report Number
- 2024168-2024-11770
- Event Type
- Injury
- Date Received
- October 7, 2024
- Date of Event
- August 8, 2024
- Report Date
- February 11, 2025
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- UDI-DI
- 08717648113154
- PMA / PMN Number
- P960043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: PRIMARY UDI NUMBER ¿ THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. SERIOUS INJURY MAY BE ASSOCIATED WITH ANY REPORTED DEVICE MALFUNCTION, POTENTIAL USE ERROR, OR CASE INVOLVING A NO-FAULT TYPE PATIENT EFFECT. IN THIS CASE, THE DEATH IS DETERMINED TO NOT BE RELATED TO THE DEVICE BASED ON THE PHYSICIAN OPINION. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. PER THE REPORTED INFORMATION, ¿THE IMPELLA CAUSED IRREVERSIBLE DAMAGE AND HEMORRHAGING TO A NON-ACCESS SITE ARTERY. A PROSTYLE DEVICE WORKED AS INTENDED AT THE ACCESS SITE AND DID NOT CAUSE OR CONTRIBUTE.¿ (THE DEVICE WAS CONFIRMED AS A PROGLIDE). 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. D4- MODEL AND CATALOG NUMBER UPDATED FROM UNK PROGLIDE TO 12673-05. D4 - LOT # UPDATED FROM UNKNOWN TO 4052241. D4 - PRIMARY UDI NUMBER UPDATED FROM UNKNOWN TO (B)(4). H11 - ADDITIONAL MFG NARRATIVE CORRECTION.
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. PER THE REPORTED INFORMATION, ¿THE IMPELLA CAUSED IRREVERSIBLE DAMAGE AND HEMORRHAGING TO A NON-ACCESS SITE ARTERY. A PROSTYLE DEVICE WORKED AS INTENDED AT THE ACCESS SITE AND DID NOT CAUSE OR CONTRIBUTE." THEREFORE, THE CAUSE OF THE REPORTED EVENT IS DETERMINED TO NOT BE RELATED TO THE DEVICE BASED ON THE PHYSICIAN OPINION. 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. B1: ADVERSE EVENT/PRODUCT PROBLEM UPDATED. B2: OUTCOMES ATTRIBUTED TO AE UPDATED FROM REQUIRED INTERVENTION TO NA. B3: DATE OF EVENT UPDATED FROM 8/5/2024 TO 8/8/2024. B5: DESCRIBE EVENT OR PROBLEM UPDATED. D1: BRAND NAME UPDATED FROM PERCLOSE PROGLIDE¿ TO PERCLOSE¿ PROSTYLE¿. D4: MODEL AND CATALOG NUMBER UPDATED FROM UNK PROGLIDE TO UNK PROSTYLE. D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM ASKU TO NO. E1: FIRST, LAST NAME UPDATED FROM VANESSA RUBESCH-KUETEMEYER TO DIRK HARTEL. H6: ADVERSE EVENT PROBLEM CODES 1888, 4641, 2610 REMOVED AND 2993, 4582, 2199 ADDED.
IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE RELATIVE TO AN IMPELLA REPOSITIONING PROCEDURE. REPORTEDLY, THE PROGLIDE SYSTEM FAILED. THE PATIENT EXPERIENCED HEMORRHAGING. AN UNSPECIFIED METHOD WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT PASSED AWAY IN THE WARD DUE TO POOR HEALTH. IT WAS REPORTED THE USE OF THE PROGLIDE DEVICE HAD NO INFLUENCE ON THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.
SUBSEQUENT TO PREVIOUSLY FILED REPORT: THE MANUFACTURER WAS NOT AWARE OF THE EVENT UNTIL IT WAS RECEIVED FROM BFARM. THE ABBOTT SALES REPRESENTATIVE SPOKE TO THE PHYSICIAN PERFORMING THE PROCEDURE (DR. (B)(6)) WHO STATED: THE PATIENT'S HEALTH WAS SEVERELY COMPROMISED PRIOR TO THE HEART PUMP REPOSITIONING PROCEDURE. DURING THE REPOSITIONING OF THE HEART PUMP, THE ARTERY SUFFERED IRREVERSIBLE DAMAGE THAT RESULTED IN AN UNSTOPPABLE HEMORRHAGE CONTRIBUTING TO THE PATIENT¿S DEATH. THE LOCATION OF THE DAMAGE WAS NOT SPECIFIED, ONLY DESCRIBED AS NON-CORONARY / NON-FEMORAL ARTERY. THE PROGLIDE DEVICE WORKED AS INTENDED, SEALING THE ACCESS SITE PUNCTURE. THE DEATH WAS DUE TO THE EXTENSIVE DAMAGE CAUSED BY THE HEART PUMP AND THE PATIENT'S POOR STATE OF HEALTH. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF AN UNKNOWN VESSEL USING A PROGLIDE RELATIVE TO AN IMPELLA REPOSITIONING PROCEDURE. REPORTEDLY, THE PROGLIDE SYSTEM FAILED. THE PATIENT EXPERIENCED HEMORRHAGING. AN UNSPECIFIED METHOD WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT PASSED AWAY IN THE WARD DUE TO POOR HEALTH. IT WAS REPORTED THE USE OF THE PROGLIDE DEVICE HAD NO INFLUENCE ON THE PATIENT'S DEATH. SUBSEQUENT TO PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THIS WAS A VESSEL CLOSURE OF A COMMON FEMORAL ARTERY. THE PATIENT PRESENTED WITH MAJOR HEART FAILURE. AN IMPELLA WAS USED FOR CORONARY SUPPORT. DURING IMPELLA REPOSITIONING, THE IMPELLA CAUSED IRREVERSIBLE DAMAGE AND HEMORRHAGING TO A NON-ACCESS SITE ARTERY. A PROSTYLE DEVICE WORKED AS INTENDED AT THE ACCESS SITE AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268396 | PERCLOSE PROGLIDE¿ | DEVICE, HEMOSTASIS, VASCULAR | MGB | ABBOTT VASCULAR INC. | 12673-05 | 4052241 | 08717648113154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |