MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-06-19 for EXPRO ELITE SNARE 6600-015 manufactured by Vascular Solutions, Inc.
[77843658]
This event occured in (b)(6). Per us: similar device identified as: brand name: expro elitre snare. Common-device name: snare. The 510(k) 071457. One expro elite snare was returned to vsi for evaluation. The loop coil had broken just distal to the intact joint coil. As no non-conformities were found in the manufacturing records and the most likely root cause is excessive force applied by the user, no corrective action is required.
Patient Sequence No: 1, Text Type: N, H10
[77843659]
Physician tried to catch a line of port catheter with expro elite snare, by doing this the tip of the snare was lost in the body of the patient. The catheter was retrieved and tip of snare was left in patient. Patient recovered without symptoms. Percutaneous intervention was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2017-00057 |
| MDR Report Key | 6649676 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-06-19 |
| Date of Report | 2016-05-03 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2015-02-28 |
| Date Added to Maude | 2017-06-19 |
| 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 | MS MARY HAUFEK |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564230 |
| Manufacturer G1 | VASCULAR SOLUTIONS, INC |
| Manufacturer Street | 6464 SYCAMORE COURT NORTH |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55369 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRO ELITE SNARE |
| Generic Name | SNARE |
| Product Code | MMX |
| Date Received | 2017-06-19 |
| Returned To Mfg | 2016-09-22 |
| Model Number | 6600-015 |
| Lot Number | 581242 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS, INC |
| Manufacturer Address | 6464 SYCAMORE COURT NORTH MINNEAPOLIS MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-19 |