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

Catalog Number D133605IL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was visually inspected, and it was found in good condition.Then, during the second visual inspection, the catheter did not deflect, and it was found that the t-bar slipped and there was exposed metal.Then, electrical testing was performed on the catheter and it was found within specification.No electrical malfunctions were observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.The catheter failed the deflection test.The catheter was analyzed under an x-ray machine and it was noticed that the t-bar slid down from its place.A manufacturing record evaluation was performed for the finished device 30209861m number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.There was a previous investigation to reduce t-bar slippage issue and it could be related to the usage of the device.Afterwards, the t-bar exposed could be related to the shipping/handling process of the device.Additionally, the customer provided a photo of the carto 3 system display.An evaluation was performed, and no impedance was observed on the photo provided.The customer complaint was confirmed from the photo.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which the biosense webster, inc.Product analysis lab identified that the t-bar slipped and there was metal exposed.Initially it was reported that during the procedure, the impedance was not displayed.The catheter was replaced, and the procedure was completed.There was no patient consequence.The no impedance issue was assessed as a not reportable issue, since the impedance is not displayed, the device can¿t be used.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On november 12, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation and upon initial visual inspection, and it was reported that there was no visual damage or anomalies observed.On december 12, 2019, during additional analysis and testing, it was confirmed that the integrity of the device was compromised.These findings were reviewed and determined to be mdr reportable as a malfunction.This event was originally considered not mdr reportable, however, biosense webster, inc.Became aware of the reportable malfunction through additional analysis and testing on december 12, 2019 and have reassessed this complaint as reportable.Therefore, the awareness date for this reportable lab finding is december 12, 2019.

Manufacturer Narrative

Additional information was received on january 6, 2020 providing the initial reporter address.Therefore, the appropriate fields in section e1.Have been populated.Initial reporter complete address is: 25 fanfan road, tianqiao district, jinan city, shandong province, china.Manufacturer's reference #: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9566196
• MDR Text Key: 199279439
• Report Number: 2029046-2020-00038
• 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
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Catalogue Number: D133605IL
• Device Lot Number: 30209861M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1