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 2018-10-11 for EXPRO ELITE SNARE 8403 manufactured by Vascular Solutions, Inc.
[123399637]
A returned product evaluation was completed and confirmed the complaint received; the radiopaque loop was separated from the device and the loop coils were unraveled. Based on the observed tensile break, the most likely root cause can be related to the tensile strength of the wire being exceeded. It is likely that the physician caught and pulled the snare loop in such a way that excessive force was exerted on the snare wire at the location of the separation. A manufacturing record review was completed and zero nonconformances were found, thus supporting that the device met material, assembly, and performance specifications prior to shipment.
Patient Sequence No: 1, Text Type: N, H10
[123399638]
Physician was using expro snare to remove an ivc filter. Snare broke and piece remained inside patient; removed with another device. Additional info rec'd 18sep2018: per physician, helical portion of snare unscrewed from catheter when spun to capture ivc hook. What was left in patient was removed with an endobrachial forceps. Current patient condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134812-2018-00072 |
| MDR Report Key | 7956488 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2017-01-25 |
| Date Added to Maude | 2018-10-11 |
| 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 | 2018-10-11 |
| Returned To Mfg | 2018-09-24 |
| Model Number | 8403 |
| Lot Number | 602448 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-10-11 |