MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-25 for MERIT CUSTOM KITS K12T-06536 manufactured by Merit Medical Richmond.
[186546879]
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[186546880]
The account alleges that during an intravascular procedure, a guidewire tip detached within the patient's artery. The clinician was successful in removing the foreign body with a vascular snare device. No patient injury to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125782-2020-00001 |
| MDR Report Key | 9881122 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2020-01-28 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer G1 | MERIT MEDICAL RICHMOND |
| Manufacturer Street | 12701 N KINGSTON AVE |
| Manufacturer City | CHESTER, VA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIT CUSTOM KITS |
| Generic Name | CUSTOM KIT |
| Product Code | DQR |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | K12T-06536 |
| Lot Number | T1728233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL RICHMOND |
| Manufacturer Address | 12701 N KINGSTON AVE CHESTER, VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |