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 2005-05-05 for ULTRACINCH ACCESSORY KIT, UC-ACC-1 11486 manufactured by Epicor Medical, Inc..
[388949]
It was reported during an open chest procedure for mitral valve replacement, following preparation of the vena cava inferior and the vena cava superior, the range around the pulmonary veins (pv's) was measured. For this purpose, the heart was lifted and the measurement tool from the accessory kit was placed around the pv's to take a measurement for determining catheter size. The pt immediately became unstable and was placed on a heart bypass machine under emergency conditions and the attempt to perform the af-ablation was terminated. The pt was reportedly doing well. Additional info received in 2005 - the physician stated there is no alleged product deficiency. A st. Jude medical rep was not present during the case. The importance of having a rep present was reiterated to the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003870001-2005-00001 |
| MDR Report Key | 599053 |
| Report Source | 01,05,06,07 |
| Date Received | 2005-05-05 |
| Date of Report | 2005-05-05 |
| Date of Event | 2005-04-04 |
| Date Mfgr Received | 2005-04-07 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2005-05-06 |
| 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 | 0 |
| Manufacturer Contact | CHARLOTTE GASPERLIN |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal | 55345 |
| Manufacturer Phone | 9529334700 |
| Manufacturer G1 | EPICOR MEDICAL, INC. |
| 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 ACCESSORY KIT, UC-ACC-1 |
| Generic Name | ULTRACINCH ACCESSORY KIT, UC-ACC-1 |
| Product Code | NTB |
| Date Received | 2005-05-05 |
| Returned To Mfg | 2005-04-18 |
| Model Number | NA |
| Catalog Number | 11486 |
| Lot Number | 04121401 |
| ID Number | NA |
| Device Expiration Date | 2007-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 588881 |
| Manufacturer | EPICOR MEDICAL, INC. |
| Manufacturer Address | * SUNNYVALE CA * US |
| Baseline Brand Name | ULTRACINCH ACCESSORY KIT |
| Baseline Generic Name | ULTRACINCH ACCESSORY KIT |
| Baseline Catalog No | 11486 |
| Baseline ID | NA |
| Baseline Device Family | ULTRACINCH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K040641 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-05-05 |