MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for AMPLATZ manufactured by Boston Scientific Corporation.
[102762897]
Patient Sequence No: 1, Text Type: N, H10
[102762898]
During picc insertion into the patient's neck, the guide wire was lost. The wire ended up migrating into patient's superior vena cava, which required surgical intervention to retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7348757 |
| MDR Report Key | 7348757 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-01-26 |
| Report Date | 2018-01-31 |
| Date Reported to FDA | 2018-01-31 |
| Date Reported to Mfgr | 2018-01-31 |
| Date Added to Maude | 2018-03-19 |
| 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 | AMPLATZ |
| Generic Name | GUIDE WIRE |
| Product Code | GCC |
| Date Received | 2018-03-19 |
| Lot Number | 21312110 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-19 |