MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for SOFT-VU SIZING ANGIOGRAPHIC CATHETER H787107323015 manufactured by Angiodynamics, Inc.
[188554137]
The reported defective device has yet to be returned to the manufacturer for a device evaluation. The firm 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
[188554138]
A patient of unknown age and gender presented for an angiographic procedure using a softvu angiographic catheter. Prior to insertion, the treating physician was loading the catheter onto the guidewire when the tip of the catheter detached. The device was set aside and a new of the same device was used to successfully complete the procedure. There was no harm or injury to the patient due to this event. It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2020-00017 |
| MDR Report Key | 9805810 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-10-05 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| 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 | SOFT-VU SIZING ANGIOGRAPHIC CATHETER |
| Generic Name | SOFT-VU SIZING ANGIOGRAPHIC CATHETER |
| Product Code | DQO |
| Date Received | 2020-03-09 |
| Catalog Number | H787107323015 |
| Lot Number | 5240497 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |