MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for SHOCKWAVE S4 3.0MM X 40MM S4IVL3040 manufactured by Shockwave Medical, Inc..
[185722118]
Md advanced shockwave device into the right coronary artery, inflated balloon to manufacturer's recommended nominal pressure. Md noted balloon ruptured. Balloon removed intact, no harm to patient. No changes in heart rhythm or hemodynamics. Md successfully used new shockwave device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902688 |
| MDR Report Key | 9902688 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-24 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | SHOCKWAVE S4 |
| Generic Name | PERCUTANEOUS CATHETER, ULTRASOUND |
| Product Code | PPN |
| Date Received | 2020-03-31 |
| Model Number | 3.0MM X 40MM |
| Catalog Number | S4IVL3040 |
| Lot Number | P191120G |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHOCKWAVE MEDICAL, INC. |
| Manufacturer Address | 5403 BETSY ROSS DRIVE SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |