MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-28 for TANDEMHEART TRANSSEPTAL CANNULA 5140-6221 manufactured by Cardiacassist Inc..
[187865504]
It was reported that the patient developed an atrial flutter with rvr (rapid ventricular response) during insertion of transpuncture. It was reported that the patient was given adenosine and was cardioverted and started on anticoagulation. The patient remained asymptomatic from the rhythm. The relationship was identified as due to "tandemheart insertion procedure. " the event occurred during insertion, and the outcome was resolved. No further relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2531527-2020-00013 |
| MDR Report Key | 9771327 |
| Report Source | STUDY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-28 |
| 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. NJEMILE CRAWLEY |
| Manufacturer Street | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | CARDIACASSIST INC. |
| Manufacturer Street | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TANDEMHEART TRANSSEPTAL CANNULA |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-28 |
| Model Number | 5140-6221 |
| Catalog Number | 5140-6221 |
| Lot Number | 2019070624 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIACASSIST INC. |
| Manufacturer Address | 620 ALPHA DRIVE PITTSBURGH PA 15238 US 15238 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |