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 2020-01-10 for HEARTSPAN TRANSSEPTAL NEEDLE 00884450169704 FND-019-01 manufactured by Merit Medical Systems Inc..
[189032707]
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
[189032708]
The account alleges that during a pvi ablation procedure, a heartspan sheath and needle were used for trasseptal puncture. During mapping of the left atrium, it was noted that the patient's blood pressure was dropping. A pericardial effusion was noted and the case was aborted. The physician performed a pericardiocentesis, but the patient's condition did not stabilize. A surgeon then performed a pericardial window to find the perforation and was unsuccessful. A sternal incision was then performed where a perforation of the left atrial appendage was discovered and successfully closed. The patient was released from the hospital without further injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529252-2020-00001 |
| MDR Report Key | 9577988 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-13 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-01-10 |
| 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 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 65 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSPAN TRANSSEPTAL NEEDLE |
| Generic Name | TRANSSEPTAL NEEDLE/TROCAR |
| Product Code | DRC |
| Date Received | 2020-01-10 |
| Model Number | 00884450169704 |
| Catalog Number | FND-019-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-10 |