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

Model Number D134805

Device Problems Device Alarm System (1012); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was initially reported by the customer that during ablation an air bubble error occurred, so the thermocool® smart touch® sf bi-directional navigation catheter was removed and reverse blood flow into the catheter (where the spring coil is located) was confirmed.The catheter was exchanged and the action was completed.There were no patient consequences.The customer¿s reported issue of bubble error warning is not mdr reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is low.The customer¿s reported blood flow into the pebax (where the spring coil is located) was assessed as not mdr reportable since there is no damage to the pebax integrity that could cause the foreign material travels into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 27-aug-2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, pal revealed that visual inspection of the device found a hole in the pebax with reddish material inside.This finding was reviewed and determined to be an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on (b)(6) 2021 and reassessed it as mdr reportable.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and irrigation evaluation of the returned device.Visual analysis of the returned sample revealed a hole with reddish-brown material in the pebax.The root cause of the pebax breakage cannot be established.All units are inspected prior leaving the facility to avoid these types of damages prior leaving the facility.Cool flow pump and pressure gage test were performed in accordance with bwi procedures.The device was working correctly, and no issues or bubble alarms were detected during the analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The customer¿s complaint regarding foreign material inside the pebax was confirmed.Regarding bubble error, 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 analysis.It should be noted that product failure is multifactorial.For product bubble error failure, the instructions for use contain the following recommendations: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12756264
• MDR Text Key: 284370698
• Report Number: 2029046-2021-01892
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30550544M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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: SMARTABLATE IRR TUBE SET; SMARTABLATE IRR TUBE SET; THMCL SMTCH SF BID, TC, D-F