MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-24 for TCI - TUMESCENT CATHETER INVERSION SYSTEM 7210023 manufactured by Smith & Nephew Inc., Endoscopy Division.
[609533]
During the case, the surgeon was stripping the vein and the green tip of the catheter came off and remains in the patient. Sales rep indicated, the green piece inside the patient will not be removed. The doctor stated, the material inside the patient is sterile. The doctor was asked if he wanted to do an ultrasound to locate the material, but refused. There will be no removal of the part.
Patient Sequence No: 1, Text Type: D, B5
[7819806]
Device is not being returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216828-2007-00025 |
| MDR Report Key | 841421 |
| Report Source | 05,07 |
| Date Received | 2007-04-24 |
| Date of Report | 2007-04-20 |
| Date of Event | 2007-03-19 |
| Date Facility Aware | 2007-03-19 |
| Report Date | 2007-04-20 |
| Date Mfgr Received | 2007-03-20 |
| Device Manufacturer Date | 2006-09-30 |
| Date Added to Maude | 2007-04-27 |
| 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 | NONE |
| Product Code | GAJ |
| Date Received | 2007-04-24 |
| Model Number | 7210023 |
| Lot Number | 60849013 |
| Device Expiration Date | 2009-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MONTH |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 828702 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| Manufacturer Address | ANDOVER MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-24 |