MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-13 for ULTRASOUND MAK KIT K12T-05493A manufactured by Merit Medical Richmond.
[123821749]
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[123821750]
The account alleges that during selective coronary angiography [sca] procedure, the stiff dilator detached from its hub. The physician had acquired access to the patient's artery via seldinger technique. While removing the stiff dilator and access wire together, the dilator detached from the hub of the introducer and remained in the access catheter. The physician was able to remove both the dilator and the catheter together. Secondary access was obtained, and the procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125782-2018-00025 |
| MDR Report Key | 7963737 |
| Date Received | 2018-10-13 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2018-09-04 |
| Date Added to Maude | 2018-10-13 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL RICHMOND |
| Manufacturer Street | 12701 N KINGSTON AVE |
| Manufacturer City | CHESTER VA 23836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRASOUND MAK KIT |
| Generic Name | ACCESS KIT |
| Product Code | OEQ |
| Date Received | 2018-10-13 |
| Returned To Mfg | 2018-11-06 |
| Catalog Number | K12T-05493A |
| Lot Number | T1418030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL RICHMOND |
| Manufacturer Address | 12701 N KINGSTON AVE CHESTER VA 23836 US 23836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-13 |