MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-03 for PROLINE SGW-015-15 * manufactured by Galt Medical Corp..
[443475]
During a picc placement in a small vein (approximately 1mm. Diameter) the vessel became spasmodic. The wire was retracted and the distal section (coil) detached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649395-2005-00002 |
| MDR Report Key | 672679 |
| Report Source | 05 |
| Date Received | 2005-09-03 |
| Date of Report | 2005-09-02 |
| Date of Event | 2005-08-03 |
| Date Mfgr Received | 2005-08-03 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-02-10 |
| 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 Street | 2475 MERRITT DRIVE |
| Manufacturer City | GARLAND TX 75041 |
| Manufacturer Country | US |
| Manufacturer Postal | 75041 |
| Manufacturer Phone | 9722715177 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLINE |
| Generic Name | GUIDEWIRE |
| Product Code | DOX |
| Date Received | 2005-09-03 |
| Returned To Mfg | 2005-08-08 |
| Model Number | SGW-015-15 |
| Catalog Number | * |
| Lot Number | F46505 |
| ID Number | * |
| Device Expiration Date | 2009-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 662002 |
| Manufacturer | GALT MEDICAL CORP. |
| Manufacturer Address | * GARLAND TX 75041 US |
| Baseline Brand Name | PROLINE |
| Baseline Generic Name | GUIDEWIRES |
| Baseline Model No | SGW-015-15 |
| Baseline Catalog No | SGW-015-15 |
| Baseline Device Family | GUIDEWIRES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K982559 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-03 |