MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-24 for MANOSCAN AR 3D PROBE 3885 manufactured by Given Imaging Los Angeles Llc.
[146078184]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146078185]
According to the reporter, the sheath balloon broke of the catheter when doctor removed it from the patient with 30cc of air still in the balloon. The physician attempted to remove the balloon from the patient without success and advised that the balloon will pass. There was no patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2019-00008 |
| MDR Report Key | 8640776 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date Mfgr Received | 2019-05-03 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-05-24 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANOSCAN AR 3D PROBE |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2019-05-24 |
| Model Number | 3885 |
| Catalog Number | 3885 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |