MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-02 for IVL PERIPHERAL BALLOON DILATATION CATHETER 60109-3560 M5IVL3560 manufactured by Shockwave Medical, Inc.
| Report Number | 3010940016-2019-00003 |
| MDR Report Key | 8755895 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-07-02 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-09 |
| Date Added to Maude | 2019-07-02 |
| 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. RYAN KIRTLAND |
| Manufacturer Street | 5403 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal | 95054 |
| Manufacturer Phone | 4085502607 |
| Manufacturer G1 | SHOCKWAVE MEDICAL INC |
| Manufacturer Street | 48501 WARM SPRINGS BLVD SUITE 108 |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94539 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVL PERIPHERAL BALLOON DILATATION CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2019-07-02 |
| Model Number | 60109-3560 |
| Catalog Number | M5IVL3560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-07-02 |