MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM PN-004 075 PN-004075 manufactured by Venusa De Mexico S.a. De C.v..
[183749319]
One tacticath quartz contact force ablation catheter was received for evaluation. The device was returned due to noise. Multiple short circuits were noted, consistent with the reported noise. Fluid was noted outside of the irrigation tubing but within the tygon tubing proximal to the catheter handle. In addition, dried saline was noted within the connector plug, consistent with the short circuits detected. Further testing revealed a leak at the luer/irrigation tubing junction due to a gap in the adhesive between the irrigation tube and the proximal tube inside the luer lock, allowing fluid to flow outside of the irrigation tubing and into the proximal tubing towards the optical and electrical connectors, consistent with the dried saline noted within connector plug.
Patient Sequence No: 1, Text Type: N, H10
[183749320]
This report is to advise of an event observed during analysis confirming a tygon tubing leak and short circuit of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680001-2020-00012 |
| MDR Report Key | 9804953 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2019-07-29 |
| Date Added to Maude | 2020-03-09 |
| 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, 75MM |
| Generic Name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OAE |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-06 |
| Model Number | PN-004 075 |
| Catalog Number | PN-004075 |
| Lot Number | 6884772 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-09 |