MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2003-08-18 for CRAGG-MCNAMARA VALVED INFUSION CATHETER 41048-01 manufactured by Micro Therapeutics, Inc..
[292668]
During use, the catheter marker band dislodged into the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2003-00031 |
| MDR Report Key | 478755 |
| Report Source | 05,08 |
| Date Received | 2003-08-18 |
| Date of Report | 2003-07-17 |
| Date of Event | 2003-05-23 |
| Date Mfgr Received | 2003-07-17 |
| Date Added to Maude | 2003-08-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | TOM DAUGHTERS |
| Manufacturer Street | 2 GOODEYAR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9498373700 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. |
| Manufacturer Street | 2 GOODYEAR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRAGG-MCNAMARA VALVED INFUSION CATHETER |
| Generic Name | INFUSION CATHETER |
| Product Code | JCY |
| Date Received | 2003-08-18 |
| Model Number | 41048-01 |
| Catalog Number | 41048-01 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 467564 |
| Manufacturer | MICRO THERAPEUTICS, INC. |
| Manufacturer Address | 2 GOODYEAR IRVINE CA 92618 US |
| Baseline Brand Name | CRAGG-MCNAMARA VALVED INFUSION CATHETER |
| Baseline Generic Name | INFUSION CATHETER |
| Baseline Model No | 41048-01 |
| Baseline Catalog No | 41048-01 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-18 |