MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: the customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the catheter became knotted.It was initially reported by the customer that the catheter was bent and a second catheter was used to completed the procedure.However, the customer provided a photo of the complaint catheter a review of the photo shows the catheter is knotted.This event has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 13-aug-2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 21-sep-2021, biosense webster inc.(bwi) received additional information about the reported event.It was confirmed the procedure was completed successfully.The issue was resolved by changing to another catheter to resolve the problem.The damage did not result in wires/internal components being exposed or lifted or sharp rings, however, there was resistance during insertion of the catheter.The catheter was not pre-shaped and the sheath used was an abbott l01 sheath.The reported ¿resistance with the sheath¿ issue is not considered to be an mdr reportable malfunction since interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.Device evaluation details: the product was returned to biosense webster for evaluation.On 27-sep-2021, the device evaluation was completed.Bwi conducted visual inspection, outer diameter evaluation and deflection test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch¿ electrophysiology catheter.Deflection testing was performed, in accordance with bwi procedures.The deflection mechanism passed the test; curve met the specification.Outer diameter of polyurethane margins was measured in accordance with bwi procedures.The catheter was working correctly, and the device was found within specifications.A manufacturing record evaluation was performed for the finished device [30538293m] number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.The event described could not be confirmed as the device was found with the deflection curve within specifications.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12257624
• MDR Text Key: 264471153
• Report Number: 2029046-2021-01229
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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: 04/22/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30538293M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 09/21/2021
• Supplement Dates FDA Received: 09/02/2021; 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT L01 SHEATH.; THMCL SMARTTOUCH,TC,D,C3,OBL.; THMCL SMARTTOUCH,TC,D,C3,OBL