KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
Report
- Report Number
- 1220648-2025-48439
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- October 20, 2025
- Report Date
- November 18, 2025
- Manufacturer
- ABIOMED, INC.
- Product Code
- DYB
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: ADDED CODES A0401 AND A150302 BASED ON INFORMATION IN THE COMPLAINT FILE.
OMISSION ON PRIOR REPORT TO REMOVE FROM H6 CODE A0404 AS THIS WAS REVISED TO A0401 ON PRIOR REPORT.
THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
THE IMPELLA DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. D9 UPDATED.
THE USER FACILITY REPORTED THAT DURING IMPELLA CP SUPPORT, AFTER THE INITIAL CRACK, THE PEEL-AWAY SHEATH DID NOT PEEL APART CORRECTLY. ONE FLANGE ONLY PEELED OFF ABOUT TWO INCHES OF THE SHEATH BEFORE BREAKING OFF. THE DOCTOR WAS FORCED TO PULL THE REMAINING FLANGE AGAINST THE IMPELLA CATHETER TO BREAK THE PERFORATIONS AND REMOVE THE SHEATH. PARTS WERE SAVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84190 | KIT, 14FR INTRODUCER, 13CM&25CM, STERILE | INTRODUCER (CATHETER) INTRODUCER | DYB | ABIOMED, INC. | KIT, 14FR INTRODUCER, 13CM&25CM, STERILE | S9721491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male |