MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-01-02 for MICRO-INTRODUCER KITS H787065970045 manufactured by Angiodynamics.
[96148379]
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96148380]
As reported to angiodynamics on december 05, 2017: per user medwatch (b)(4) received: the patient was admitted with diagnosis svt for ablation svt, eps with 3d mapping. While the physician was obtaining venous access to the patient's left femoral vein, the ministick wire inadvertently became knotted up and stuck in the subcutaneous tissue. The position of the wire was unchanged at the end of the study. The patient's parents were notified. Another doctor was consulted; no need to remove the piece of wire. The procedure was completed; the patient was discharged the next day. It was reported the defective disposable device is not available for return to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00002 |
| MDR Report Key | 7156789 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-01-02 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2017-10-06 |
| Date Added to Maude | 2018-01-02 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICRO-INTRODUCER KITS |
| Generic Name | MICRO-INTRODUCER KITS |
| Product Code | DQT |
| Date Received | 2018-01-02 |
| Catalog Number | H787065970045 |
| Lot Number | 5243426 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-02 |