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 2020-03-16 for TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM PN-004 065 PN-004065 manufactured by Venusa De Mexico S.a. De C.v..
[183516887]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[183516888]
Related manufacturing ref: 9680001-2020-00014. During the procedure, there was no contact force reading on the catheter. The catheter was exchanged which did not resolve the issued and the procedure was cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680001-2020-00015 |
| MDR Report Key | 9834991 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-08 |
| Date Added to Maude | 2020-03-16 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | VENUSA DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CALLE HERTZ 1525-6 PARQUE INDUSTRIAL J. BERMUDEZ |
| Manufacturer City | CIUDAD JUAREZ, CHIHUAHUA 32470 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 65MM |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OAE |
| Date Received | 2020-03-16 |
| Model Number | PN-004 065 |
| Catalog Number | PN-004065 |
| Lot Number | 6466697 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENUSA DE MEXICO S.A. DE C.V. |
| Manufacturer Address | CALLE HERTZ 1525-6 PARQUE INDUSTRIAL J. BERMUDEZ CIUDAD JUAREZ, CHIHUAHUA 32470 MX 32470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |