MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for TRANSITIONLESS MICRO-INTRODUCER KIT KIT-038-03 manufactured by Galt Medical Corp..
[131792959]
The device is not available for evaluation per health professional. Investigation and evaluation performed based on device history review and complaint history review. Device history review shows all units was manufactured to specifications and passed inspection criteria. Based on history record for last five years, this type of incident might occur due to end user error. End user might not follow instructions per (instructions for use). Per health professional statement said (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). Guidewires cannot be removed from patient body through the needle. If any obstructions or resistance occurred it is recommended to remove entire assembly from patient body not only the guidewires. Removing guidewires through the needle might lead to cut tip of coiled wire by cutting edges of the needles or guidewires might unraveled or tangled while inside patient body causing serious injury. Manufacturer recommend to end user to follow instruction for use stated as warning (do not withdraw guidewire through metal needles; guidewire may shear or unravel).
Patient Sequence No: 1, Text Type: N, H10
[131792960]
As received from health professional: 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649395-2018-00010 |
| MDR Report Key | 8171754 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-01 |
| Date Facility Aware | 2018-12-11 |
| Report Date | 2018-11-30 |
| Date Reported to FDA | 2018-11-30 |
| Date Reported to Mfgr | 2018-12-11 |
| Date Mfgr Received | 2018-12-11 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIYAR MEDHAT |
| Manufacturer Street | 2220, 6137, MERRITT DR |
| Manufacturer City | GARLAND TX 75041 |
| Manufacturer Country | US |
| Manufacturer Postal | 75041 |
| Manufacturer Phone | 9722715177 |
| Manufacturer G1 | GALT MEDICAL CORP. |
| Manufacturer Street | 2220, 6137, MERRITT DR |
| Manufacturer City | GARLAND TX 75041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSITIONLESS MICRO-INTRODUCER KIT |
| Generic Name | PERCUTANEOUS SHEATH INTRODUCER KIT |
| Product Code | OFL |
| Date Received | 2018-12-17 |
| Model Number | KIT-038-03 |
| Catalog Number | KIT-038-03 |
| Lot Number | G18194884 |
| Device Availability | N |
| Device Age | 156 DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GALT MEDICAL CORP. |
| Manufacturer Address | 2220, 6137, MERRITT DR GARLAND TX 75041 US 75041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-17 |