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 2020-02-12 for ACCU-VU SIZING ANGIOGRAPHIC CATHETER H787137098015 manufactured by Angiodynamics, Inc.
[188542855]
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event 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
[188542856]
Angiodynamics received a angiographic catheter device that the tip had detached from the catheter shaft. The device failure was not reported previously and had been returned with another sample for a different complaint record from the same account for the same failure. .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2020-00011 |
| MDR Report Key | 9699595 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2020-02-12 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-VU SIZING ANGIOGRAPHIC CATHETER |
| Generic Name | ACCU-VU SIZING ANGIOGRAPHIC CATHETER |
| Product Code | DQO |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-01-15 |
| Catalog Number | H787137098015 |
| Lot Number | 5149507 |
| Device Expiration Date | 2020-02-29 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |