MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Material Integrity Problem (2978)

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

Event Date 08/19/2017

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.Manufacturer's ref.No: (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, and during the procedure, a magnetic sensor error (402 error code) occurred.The catheter was replaced, which resolved the issue.No patient consequences were reported.The potential that a magnetic sensor error could cause or contribute to an adverse event is remote.As a result, this was not an mdr reportable event.On 9/25/2017, the bwi failure analysis lab received the device for evaluation.A preliminary visual inspection found nothing unusual about the catheter.However, on (b)(6) 2017, a second visual inspection was performed, and the pebax was found to be damaged with reddish brown material underneath.Scanning electron microscopy performed on (b)(6) 2017 confirmed these findings.Multiple attempts were made to obtain additional information regarding the condition of the returned catheter, but none was made available.The presence of reddish brown material under the pebax is an expected finding after these procedures, and is not mdr reportable.However, the damage to the pebax is reportable, as exposure to the internal catheter components presents a possible risk to the patient.The awareness date for this complaint has been reset to 10/18/2017, the date of the reportable findings.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter, and during the procedure, a magnetic sensor error (402 error code) occurred.On 9/25/2017, the bwi failure analysis lab received the device for evaluation.A preliminary visual inspection found nothing unusual about the catheter.However, on (b)(6) 2017, a second visual inspection was performed, and the pebax was found to be damaged with reddish brown material underneath.The returned device was visually inspected, and the pebax was found to be damaged with reddish material inside.The catheter was evaluated for eeprom, and the sensor functionality was tested on a carto 3 system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by the carto 3 system, but errors 105 and 106 (magnetic sensor failure and force sensor failure) were displayed.The catheter was then dissected, and it was determined that the root cause was an internal sensor failure.Per this condition, scanning electron microscopy was performed.The results showed evidence of damage with an opening on the surface of the pebax.It is possible that the damage was caused by contact with an unknown object.No other anomalies were observed.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.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the lost electrical continuity at the sensor could not be determined.Based on the available analysis finding results, the damage on the pebax does not appear to be caused by any internal bwi processes, as there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturers reference number: (b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7007867
• MDR Text Key: 92318883
• Report Number: 2029046-2017-01107
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)170615(17)180531(10)17689355L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

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: 05/31/2018
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 17689355L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2017
• 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