MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-12-05 for TCI - TUMESCENT CATHETER INVERSION SYSTEM 7210023 manufactured by Smith & Nephew Inc., Endoscopy Division.
[16128704]
Medwatch report from user facility indicates a trivex phlebectomy procedure was being performed on right leg. Two catheters were joined together at interlocking adapters (one white and one green). This catheter is then threaded into vein of leg and fluid instilled. While surgeon was pulling catheter to remove it from leg, green adapter broke from catheter end and white adapter. It was lost inside leg. This required multiple incisions to be made in attempt to locate it. Adapter found and removed by surgeon.
Patient Sequence No: 1, Text Type: D, B5
[16244348]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216828-2006-00055 |
| MDR Report Key | 2838439 |
| Report Source | 00 |
| Date Received | 2006-12-05 |
| Date of Report | 2006-12-04 |
| Date of Event | 2009-10-09 |
| Date Facility Aware | 2006-10-09 |
| Report Date | 2006-10-11 |
| Date Reported to Mfgr | 2006-10-10 |
| Date Mfgr Received | 2006-10-10 |
| Device Manufacturer Date | 2006-06-26 |
| Date Added to Maude | 2012-11-23 |
| 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 | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 160 DASCOMB RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCI - TUMESCENT CATHETER INVERSION SYSTEM |
| Generic Name | TUMESCENT CATHETER INVERSION SYSTEM |
| Product Code | GAJ |
| Date Received | 2006-12-05 |
| Returned To Mfg | 2006-10-26 |
| Model Number | 7210023 |
| Lot Number | 60847153 |
| Device Expiration Date | 2009-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| Manufacturer Address | ANDOVER MA 01810 US 0181 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-05 |