MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-30 for PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 60109-4060 M5IVL4060 manufactured by Shockwave Medical, Inc.
| Report Number | 3010940016-2019-00007 |
| MDR Report Key | 9257784 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-01 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-01 |
| Device Manufacturer Date | 2019-03-15 |
| Date Added to Maude | 2019-10-30 |
| 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 | 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 | 5403 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2019-10-30 |
| Returned To Mfg | 2019-10-08 |
| Model Number | 60109-4060 |
| Catalog Number | M5IVL4060 |
| Lot Number | P190315G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-10-30 |