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 2020-03-17 for TACTICATH? QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM PN-004 075 PN-004075 manufactured by Venusa De Mexico S.a. De C.v..
[183749566]
One tacticath? Quartz contact force ablation catheter, 75mm was returned for a contact force issue. Optical fibers 1-3 did not meet specifications for optical properties and no contact force was displayed when the catheter was connected to the tactisys quartz unit. The catheter handle was disassembled and fluid was noted to leak into the handle from its distal end. The irrigation tubing was noted to be fractured under the plunger. Optical fibers 1-3 were noted to be fractured under the plunger, consistent with the loss of contact force. The redel connector was opened and liquid was observed within the connector, consistent with the observed leak due to the fracture in the irrigation tubing. The multiple short circuits were determined to be due to this evidence of backflow into the redel connector. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The components of the handle were unable to freely rotate. Therefore, the cause of the fractured optical fibers, leak in the catheter handle, and subsequent short circuits remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[183749567]
This report is to advise of an event observed during analysis confirming an irrigation leak of the catheter and multiple short circuits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680001-2020-00013 |
| MDR Report Key | 9841438 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-02-06 |
| Model Number | PN-004 075 |
| Catalog Number | PN-004075 |
| Lot Number | 6884696 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-17 |