MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-16 for PRESTO INFLATION DEVICE ID4030 manufactured by Bard Peripheral Vascular, Inc..
[162612296]
The lot number of the device was provided. The device history records are currently under review. The return of the sample is pending. The investigation is currently underway. (expiry date: 06/2020).
Patient Sequence No: 1, Text Type: N, H10
[162612297]
It was reported that during an angioplasty procedure in the iliac vein, the monometer was allegedly not working. It was reported that the procedure was completed with the same device but no dial to determine the atms. It was further reported that the patient expired from a pulmonary embolism.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-04026 |
| MDR Report Key | 9199710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-16 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-09-19 |
| Date Added to Maude | 2019-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | FOREFRONT MEDICAL TECHNOLOGY |
| Manufacturer City | CHANGZHOU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTO INFLATION DEVICE |
| Generic Name | INFLATION DEVICE |
| Product Code | MAV |
| Date Received | 2019-10-16 |
| Model Number | ID4030 |
| Catalog Number | ID4030 |
| Lot Number | PID1906076 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-10-16 |