MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-21 for IMPELLA RP 004334 manufactured by Abiomed, Inc..
[128192613]
The impella rp was received and a failure investigation was conducted. Kinks and general deformation was confirmed and support the reported allegation. A review of the data logs confirmed placement signal reduction. A review of the device history record found no manufacturing issues or reworks associated with this pump. There are no other complaints associated with pumps from this lot. The loss of position and cannula kinking on itself most likely occurred during the vt storms and defibrillation of the patient, but the definitive cause of the pump losing position and kinking is unknown.
Patient Sequence No: 1, Text Type: N, H10
[128192614]
The complainant reported a (b)(6) year old caucasian male presenting with right heart failure. An impella rp was inserted without issue. Patient endured 4 sustained vt events, which were alleviated by way of patient's internal defibrillator. During procedure, a kink was discovered in the cannula and was described as "coiled. " due to malformed cannula, surgical intervention was performed to remove the rp to avoid serious injury to patient during explant. A new rp pump was inserted and operated successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00156 |
| MDR Report Key | 8096567 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2018-05-29 |
| Date Added to Maude | 2018-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DR. |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED, INC. |
| Manufacturer Street | 22 CHERRY HILL DR. |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-10-09 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1341178 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR. DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-21 |