MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-11-10 for ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9 12544 manufactured by St. Jude Medical.
[1807783]
It was reported during ablation, the physician noticed that the plastic sleeve around the electrical cable and rinsing tubes disconnected from the cinch. The proximal connector moved below the svc so after complete ablation, the electrical cable had to be cut ro remove the ultracinch device. There were no consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8906725]
We are awaiting device return. When our investigation has been completed, a follow up report will be submitted. Date report submitted to fda by manufacturer: (b)(4) 2010. Date the initial reporter provided the information to the manufacturer: (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003870001-2010-00013 |
| MDR Report Key | 1907130 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-11-10 |
| Date of Report | 2010-10-14 |
| Date of Event | 2010-10-14 |
| Date Mfgr Received | 2010-10-14 |
| Date Added to Maude | 2011-06-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SETH KERSTEN |
| Manufacturer Street | ONE ST. JUDE MEDICAL DR |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517562000 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 240 SANTA ANA COURT |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9 |
| Generic Name | UC-LP-9 |
| Product Code | NTB |
| Date Received | 2010-11-10 |
| Model Number | 12544 |
| Catalog Number | 12544 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-10 |