MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-02 for MICRO-INTRODUCER KITS H787065970015 manufactured by Angiodynamics, Inc.
[140657764]
It was reported that the disposable device 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. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140657765]
During a hepatic artery embolization procedure in ir lab radiology, a micro catheter kit was used. The dilator was advanced over a cope wire, cope wired removed, dilator remained, wire passed thru and when removed, the hub was fractured and the lower portion of the dilator remained in the patient. The treating physician attempted to retrieve the piece but was unsuccessful. Vascular and general surgery were contacted. On the day following the procedure, the ir radiologist brought the patient back to the lab and successfully 'snagged' the broken piece. 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 | 1319211-2019-00032 |
| MDR Report Key | 8474758 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-02 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-02 |
| 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 | 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 | 2019-04-02 |
| Catalog Number | H787065970015 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-02 |