MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for TRANSITIONLESS MICRO-INTRODUCER KIT KIT-038-03 manufactured by Galt Medical Corp..
[128887963]
Patient was prepped/ draped in sterile fashion. Per cardiologist's notes: a percutaneous needle stick was achieved through the left subclavian vein. A guidewire was then inserted into the left subclavian vein. Resistance was met and while retracting the wire, the tip broke off. Contrast angiography was performed demonstrating that the wire was not intravascular. Access was then again achieved via micropuncture under angiography. Manufacturer response for percutaneous sheath introducer kit, transitionless micro-introducer kit (per site reporter). Reported by the cardiac cath lab manager to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8119529 |
| MDR Report Key | 8119529 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-10-09 |
| Report Date | 2018-11-20 |
| Date Reported to FDA | 2018-11-20 |
| Date Reported to Mfgr | 2018-11-30 |
| Date Added to Maude | 2018-11-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSITIONLESS MICRO-INTRODUCER KIT |
| Generic Name | PERCUTANEOUS SHEATH INTRODUCER KIT |
| Product Code | OFL |
| Date Received | 2018-11-30 |
| Model Number | KIT-038-03 |
| Catalog Number | KIT-038-03 |
| Lot Number | G18194884 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GALT MEDICAL CORP. |
| Manufacturer Address | 2220 MERRITT DR GARLAND TX 75041 US 75041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |