MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for HEARTSPAN TRANSSEPTAL NEEDLE 00884450169704 FND-019-02 manufactured by Merit Medical Systems Inc..
[188624963]
The suspect device is not expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[188624964]
The account alleges that during a transseptal puncture a needle was used to puncture the septum. The physician noted under fluoroscopy, that a pericardial puncture had occurred. The procedure was then terminated, and an echocardiogram performed. The pericardial effusion could not be identified or documented. The patient remained stable and was transferred to the intensive care unit [icu] for further observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529252-2020-00004 |
| MDR Report Key | 9826406 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-06-20 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| 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 Phone | 2084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 65 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSPAN TRANSSEPTAL NEEDLE |
| Generic Name | TRANSSEPTAL NEEDLE |
| Product Code | DRC |
| Date Received | 2020-03-12 |
| Model Number | 00884450169704 |
| Catalog Number | FND-019-02 |
| Lot Number | Q1565421 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 65 GREAT VALLEY PARKWAY MALVERN, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2020-03-12 |