MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for FIBEROPTIX ULTRA 8 IAB: 8FR 40CC IPN000254 IAB-05840-LWS manufactured by Arrow International Inc..
[185516508]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185516509]
It was reported that the intra-aortic balloon (iab) was inserted trans-thoracically into the aorta due to femoral access issues and the catheter burst. As a result, the iab was removed and replaced. There was no report of patient complications, serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010532612-2020-00083 |
| MDR Report Key | 9897274 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-30 |
| 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 | JONATHAN KIMCHAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBEROPTIX ULTRA 8 IAB: 8FR 40CC |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC |
| Product Code | DSP |
| Date Received | 2020-03-30 |
| Model Number | IPN000254 |
| Catalog Number | IAB-05840-LWS |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |