MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for BARD LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 5F, 6 MM X 150 MM X 130 CM 9004 manufactured by Cr Bard, Inc..
[110137245]
Left lower extremity peripheral intervention was performed. Attempted to remove the bard lutonix 6. 0 x 150 mm balloon but there was difficulty. All equipment including sheath, wire and balloon were removed. Manual compression was applied by the physician. Upon examination of equipment removed it was apparent that the balloon was sheared off and fully contained inside the sheath. No foreign body left behind.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077608 |
| MDR Report Key | 7565011 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-05-24 |
| Date Added to Maude | 2018-06-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 5F, 6 MM X 150 MM X 130 CM |
| Generic Name | DRUG-COATED PERIPHERAL TRANSLUMINAL |
| Product Code | PRC |
| Date Received | 2018-06-01 |
| Model Number | 9004 |
| Lot Number | GFBY3509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CR BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-01 |