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

Model Number D-1336-01-S

Device Problems Bent (1059); Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2015

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a smart touch unidirectional catheter and a force issue and magnetic sensor error occurred.At end of the procedure the contact force of the smart touch catheter was displayed as "na" during the ablation.A magnetic sensor error appeared at the same time the ablation was started although there were no other catheters near the smart touch catheter.The case was continued with the issue.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event was originally assessed as not reportable as both of these errors are highly detectable and the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2015 the device was received for analysis at the bwi failure analysis lab where it was discovered that the shaft was bent and wrinkled with broken braid wire exposed 13.5mm from the transition with the tip lumen.The shaft was also bent and wrinkled next to thumb knob.This finding has been assessed as reportable since there is braid wire exposed which could cause potential harm to the patient.The awareness date for this record is (b)(6) 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a smart touch unidirectional catheter and a force issue and magnetic sensor error occurred.The returned catheter was visually inspected and the shaft was broken with braid wire exposed and brownish material at 13.5mm from the transition with the tip lumen.It is unknown how this condition was generated however it appears the damage could be related to external force on the catheter shaft.The condition was not reported by the customer and it was reported there was no information that there was difficulty during withdrawal from the patient.An internal corrective action was created to address the thermocool smart touch broken shaft issue.Due to the exposed components, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.Per the reported event the catheter was evaluated for screening test and force calibration check and catheter passed both tests.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was working properly.Finally, the force sensor resistance values were found within 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 regarding a force issue cannot be confirmed.However catheter was found broken.

Manufacturer Narrative

A correction was made to the device evaluation.Initially the product analysis conclusion stated "due to the exposed components, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated." however, that is in correct, the correct information is as follows: due to the exposed components, an electrical test was performed and the catheter failed.Due the broken shaft, brownish material was found inside the shaft.Leakage was observed on electrodes 2, 5 and 6.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION 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: shahe garabedian ; 9098397362
• MDR Report Key: 4948510
• MDR Text Key: 23101947
• Report Number: 9673241-2015-00491
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 06/15/2015

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: 02/29/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17193871M
• Other Device ID Number: (01)10846835008982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2015; 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2015
• 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