MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for SHOCKWAVE LITHOPLASTY BALLOON CATHETER 7.0 MM X 60MM-110CM M732LPBC706DX1K manufactured by Shockwave Medical Inc..
[111478093]
During procedure, shockwave lithoplasty balloon popped and unable to be removed through sheath. Sheath and balloon removed together and new sheath reinserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077896 |
| MDR Report Key | 7609515 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-06-11 |
| Date Added to Maude | 2018-06-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SHOCKWAVE LITHOPLASTY BALLOON CATHETER |
| Generic Name | SHOCKWAVE LITHOPLASTY BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2018-06-15 |
| Returned To Mfg | 2018-06-14 |
| Model Number | 7.0 MM X 60MM-110CM |
| Catalog Number | M732LPBC706DX1K |
| Lot Number | $$3200430P180418BKS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHOCKWAVE MEDICAL INC. |
| Manufacturer Address | FREMONT CA 94539 US 94539 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-15 |