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 2019-05-02 for MICRO-INTRODUCER KITS H787065970155 manufactured by Angiodynamics, Inc.
[143874932]
The reported defective device has yet to be returned to the manufacturer for a device evaluation. Angiodynamics is attempting to obtain the device. An investigation into the root cause for product problem 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
[143874933]
Per received user medwatch 0504240000-2019-8006: pt undergoing cerebral angiogram the site was injected with lidocaine 1 % overlying the right common femoral artery the groin and arterial access was gained using a micropuncture technique, with the access wire in place the md went to remove the micropuncture sheath the hub disconnected from the main body of the sheath - when the md pulled on the main body of the sheath, approximately one half of it came off. Approx. 2 1/2 cm of the tip was missing and still on the wire, attempts to dissect with a hemostat down the wire to identify and remove - unsuccessful attempt. The left common femoral artery was accessed with ultrasound guidance, a 6f 11 cm sheath was placed and flushed, through this a snare was used to capture the distal end of the access wire and withdraw out the left femoral artery sheath - a 5cm sheath was placed over the wire into the right common femoral artery - a 70 cm kumpe was passed antegrade down the access wire and the tip of the was pushed out the left side of the groin - there was not harm to the patient all was retrieved. It was indicated the defective disposable device is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2019-00037 |
| MDR Report Key | 8575001 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-02 |
| Date of Report | 2019-08-19 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2018-01-26 |
| Date Added to Maude | 2019-05-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-05-02 |
| Returned To Mfg | 2019-05-22 |
| Catalog Number | H787065970155 |
| Lot Number | 5289467 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-02 |