MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1348-05-S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where clotting got stuck to the catheter tip.During the procedure, the catheter was removed from the patient¿s body, and the clot was discovered.The catheter was rubbed while checking it, dislodging the clot.Generator settings and controls were being used as normal.It was noted that this issue seemed to be occurring more often in the recent past.The procedure was completed without patient consequence.Multiple attempts were made to gain additional information regarding this complaint, but none was made available.Clotting/coagulum exhibits poor adherence to catheters, making it a potential source of embolism.As a result, this event is mdr reportable.

Manufacturer Narrative

On 8/19/2017, the bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where clotting got stuck to the catheter tip.The returned device was visually inspected, and was found in normal condition.No charring or clotting was observed.Per the reported event, the catheter was tested for electrical performance and stockert compatibility, and was found within specifications.A coolflow pump test was also performed, and the catheter passed specifications.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6796020
• MDR Text Key: 83741247
• Report Number: 9673241-2017-00647
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)170420(17)180331(10)17657573L
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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,Followup,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17657573L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 07/24/2017
• Supplement Dates FDA Received: 08/21/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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