MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; SIMILAR DEVICE D131801, PMA # P030031/S034

Model Number D-1318-00

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a patient, (b)(6) male, underwent a persistent atrial fibrillation (afib) procedure with a thermocool sf navigational catheter and suffered a pulmonary vein stenosis and a recurrent of an atrial fibrillation.The patient's medical history is unknown.There is no information about the hospitalization and if any intervention was performed.No information is known regarding the patient status.The physician's opinion regarding the cause of this adverse event is not known.Attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: SIMILAR DEVICE D131801, PMA # P030031/S034
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5552332
• MDR Text Key: 42037571
• Report Number: 9673241-2016-00231
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1318-00
• Device Catalogue Number: D131800
• Device Lot Number: UNKNOWN_D-1318-00-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR