MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMRTTCH,BI,NAV,TC,D-F,C3; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132705

Device Problems Crack (1135); Entrapment of Device (1212); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered device entrapment requiring surgical intervention causing prolonged surgery.During mapping in the left ventricle (lv), after about 30 min of mapping, right after re-entering ventricle from the left atrium (la), the pressure sensor started alarming on high.The physician stopped manipulating, and it is confirmed that the catheter is stuck.The sheath is unaffected and moves freely.Transthoracic echo is done.Physician hypothesis is that the catheter is entangled in the cordae.A thoracic surgery team was called, and a plan was laid.Patient was taken to an or and put under general anesthesia (ga).With transesophageal echocardiogram (tte) and manipulation, they were able to free the catheter.The customer would like to be involved and be contacted to further discuss this issue if possible.Products were not decontaminated per customer request as to not influence the catheters, sent as they are removed.Picture was sent of the catheter tip right after removal.The surgery was delayed 240 minutes due to the reported event.The procedure was not successfully completed.There were patient consequences.Patient consequence description includes emergency ga.Other medical intervention was required.The event occurred on (b)(6) 2022.Since the event required a surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The force high issue was assessed as not mdr reportable.The issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.The medical device entrapment with excessive manipulation required and the pebax cracked/broken issues were assessed as mdr reportable product malfunction.

Manufacturer Narrative

Investigation findings code of "appropriate term/code not available" represents photo/video analysis.According to the photo provided by the customer, it looked like the pebax has a cracked condition.Also, blood was noted inside the pebax.No other damages nor anomalies were observed on the photo provided.The cracked condition observed on the pebax could be the result of the entrapment condition reported by the customer, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device lot 30816270m, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.The device has not been received at the biosense webster inc.Lab for analysis and a root cause is unable to be assigned based on the current evidence.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 22-sep-2022.The device evaluation was completed on 29-sep-2022.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered device entrapment requiring surgical intervention causing prolonged surgery.During mapping in the left ventricle (lv), after about 30 min of mapping, right after re-entering ventricle from the left atrium (la), the pressure sensor started alarming on high.The physician stopped manipulating, and it is confirmed that the catheter is stuck.The sheath is unaffected and moves freely.Transthoracic echo is done.Physician hypothesis is that the catheter is entangled in the cordae.A thoracic surgery team was called, and a plan was laid.Patient was taken to an or and put under general anesthesia (ga).With transesophageal echocardiogram (tte) and manipulation, they were able to free the catheter.Device evaluation details: the product was returned to biosense webster for evaluation.Visual analysis of the returned sample revealed reddish material on the catheter.During microscopic examination of the pebax area, a hole was found in the pebax.Per the event, several tests were performed.Electrical, temperature and no issues were observed.In addition, the product was deflecting and irrigating correctly.The device was connected to the carto 3 system, and the device was visualized and recognized correctly; however, the error 105 ¿magnetic sensor error¿ appeared on the carto 3 screen.The catheter was dissected, and it was found that the tip lost the sensor's wire's continuity, causing the magnetic sensor error.A manufacturing record evaluation was performed for the finished device batch number 30816270m, and no internal actions related to the complaint were identified.The root cause of the adverse event remains unknown.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 (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THMCL SMRTTCH,BI,NAV,TC,D-F,C3
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15481430
• MDR Text Key: 300588966
• Report Number: 2029046-2022-02309
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30816270M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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: 8.5F SHEATH WITH CURVE VIZ LGC.
• Patient Outcome(s): Other