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 2019-12-30 for MINI STICK MAX H965457591 manufactured by Angiodynamics.
[176545482]
It was reported that the disposable device was discarded by the user and 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 investigation will be sent via a follow up medwatch. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176545483]
As reported: procedure: left heart cath, gaining micropuncture access. Hub detached from sheath leaving sheath inside patients right femoral artery. They had to do a cut-down in order to remove sheath from patients body. It was reported the patient did not suffer any permanent harm or injury due to this event. It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00158 |
| MDR Report Key | 9530388 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2019-12-30 |
| 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 NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS, NY NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI STICK MAX |
| Generic Name | VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2019-12-30 |
| Catalog Number | H965457591 |
| Lot Number | 5534700 |
| 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 |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-30 |