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 2019-01-29 for MICRO-INTRODUCER KITS H787065072125 manufactured by Angiodynamics, Inc.
[134413878]
The reported device is being retained by the end user for an internal investigation. Angiodynamics is attempting to obtain the device. An investigation into the root cause for product problem is currently in progress. The results of the investigation and root cause determination will be sent via a follow up medwatch. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134413879]
Customer reported a significant section of the morpheus ct guidewire (11 cm) broke off during a procedure causing a patient to have to go into emergency or surgery to remove the piece. Guidewire and catheter were placed in periappendiceal abscess in rlq of abdomen. As guidewire was being removed, floppy tip of wire sheared off and remained in patient. Surgery removed guidewire piece and patient was stable afterwards. 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 | 1319211-2019-00007 |
| MDR Report Key | 8286810 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-29 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2017-09-12 |
| Date Added to Maude | 2019-01-29 |
| 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 | 2019-01-29 |
| Catalog Number | H787065072125 |
| Lot Number | 5232811 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-29 |