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 2020-02-04 for IMPELLA RP IMPELLA RP US PUMP SET 004334 manufactured by Abiomed, Inc..
[177746453]
The impella rp was returned and an investigation is currently underway. Upon completion, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[177746454]
A (b)(6) male presented post cardiotomy cardiogenic shock while on left ventricle hemodynamic support with an impella cp. An attempt to wean and remove the cp was unsuccessful as patient's condition would intolerant. A transthoracic echocardiogram was completed and the patient's right ventricle was found dilated. Therefore, the decision was made to insert an impella rp to help improve the patient's condition enough to remove the cp. The physician chose to insert the rp in the left femoral vein due to the placement of the impella cp and due to the right common femoral vein being assessed as inaccessible with ultrasound guidance. Despite recommendations in the impella instructions for use, and advisement of clinical field representative, the physician inserted the impella rp into the patients left femoral vein. During insertion, the device endured difficulty passing the pulmonary artery. The physician felt adequate placement was achieved, despite fluoroscopic imaging showing device "far from the bifurcation. " upon removal of the guide wire, the device separated at the distal ball which connects the device's outlet cage to the pigtail. The rp was removed and a snare was utilized to remove the broken component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00333 |
| MDR Report Key | 9664208 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-01-06 |
| Date Facility Aware | 2020-01-06 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-02-04 |
| 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 | 2020-02-04 |
| Returned To Mfg | 2020-01-17 |
| Model Number | IMPELLA RP US PUMP SET |
| Catalog Number | 004334 |
| Lot Number | 1429348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-04 |