MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-05 for MICRO-INTRODUCER KITS H787065072025 manufactured by Angiodynamics, Inc.
[119249456]
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119249457]
As reported to angiodynamics on (b)(6) 2018: during a cardiac catheterization procedure, it was noted that a fragment of the guidewire broke off in the patient's right wrist. The fragment was removed under local and site sutured. It was reported the patient suffered no permanent harm or injury due to this event. 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 | 1319211-2018-00091 |
| MDR Report Key | 7847155 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-05 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-15 |
| Device Manufacturer Date | 2018-04-07 |
| Date Added to Maude | 2018-09-05 |
| 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 | RISK MANAGER |
| 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 | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC |
| 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 | 2018-09-05 |
| Catalog Number | H787065072025 |
| Lot Number | 5310430 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-05 |