MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-12 for MINI STICK MAX H965457591 manufactured by Angiodynamics.
[178782138]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178782139]
User medwatch (b)(4) received from fda on 22-jan-2020: elderly male with end stage renal disease and on dialysis, while having a heart catheter: "mini stick max micropuncture wire sheared off into patient's right groin when accessing vein. Doctor was able to snare wire. Wire was retrieved successfully under fluoroscopy. No complications present for the patient. " "patient had thick skin. We tried get micro-puncture access which was successful. However, couldn't get the micropuncture sheath over the wire. We tried to abort the access by taking out wire and noticed micropuncture wire broke with embolized piece in the right femoral vein, held in place with manual pressure on the groin. We took access in the right internal jugular vein and tried to snare the wire, which was unsuccessful and later took access in the left cfv and successfully snared the wire out. " original intended procedure was heart cath. 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 | 1317056-2020-00017 |
| MDR Report Key | 9699585 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-10-29 |
| 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 |
| 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 |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINI STICK MAX |
| Generic Name | VESSEL DILATOR |
| Product Code | DRE |
| Date Received | 2020-02-12 |
| Catalog Number | H965457591 |
| Lot Number | 5534700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |