MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 3/18/2021.The device evaluation was completed on 4/16/2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and magnetic evaluation of the returned device.Visual analysis of the returned sample revealed that reddish material and a hole in the pebax were observed on the smart touch bidirectional sf catheter.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.The damage observed on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.The event described as the icon moved erratically was unable to be duplicated during the product investigation.However, the blood found inside the pebax area may have contributed to magnetic issues, including the icon movement reported.A manufacturing record evaluation was performed, 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.The instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Regarding the additional finding observed, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc.Product analysis lab observed a hole on the pebax.Initially it was reported that upon ablation, the catheter icon would move erratically.They replaced the catheter cable, then rebooted the patient interface unit and the issue did not resolve.The catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence reported.The icon issue was assessed as not mdr reportable.The catheter icon jumping was a highly detectable issue.There was no real movement of the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster inc.Product analysis lab received the device for evaluation and observed on 3/25/2021 a hole on the pebax with reddish-brown material inside.The lab finding of the hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding is 3/25/2021.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11704900
• MDR Text Key: 273853440
• Report Number: 2029046-2021-00632
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 02/24/2021

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: 07/06/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30394452M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• 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
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER CABLE