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

Model Number D132705

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Mitral Insufficiency (1963); Rupture (2208); No Code Available (3191)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

Event Description

It was reported that a female patient (65 year old, 82kg,180cm) underwent cardiac ablation procedure for cardiac ablation with thermocool® smart touch¿ bi-directional navigation catheter and suffered medical device entrapment requiring surgical intervention.The catheter got stuck in the cordae of the papillary muscles.The physician tried to push and pull the catheter slowly to get it untrapped, but it did not work.Echo assistance was needed.After some minutes, the catheter released easily when pulling the catheter back.An echo doppler cardiograph shows a rupture in the anterolateral papillary muscle and a mitral insufficiency.The patient will go to surgery to repair the mitral annulus.Entrapment in the chordae from the anterolateral papillary muscle, resulting from (one of many previous and successful) attempts to reach the endocardial side of the left ventricle-summit area, combined with the minimal sharp edges between the different segments of the catheter tip.Careful attempts to free the device resulted in papillary muscle rupture and a mitral insufficiency demanding surgery performed the next day without the need for implantation of a mechanical valve.Uneventful postoperative period to date (september 29, 2020).Graph, dashboard, vector and visitag were used for force visualization.The visitag settings were 3 mm for 3 sec, respiratory adjustment, force over time: 25%; min force: 3 g.Ablation index for additional filter the papillary muscle rupture and mitral insufficiency may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore were assessed as mdr reportable.The medical device entrapment with excessive manipulation required and the broken tip were also assessed as mdr reportable issues.

Manufacturer Narrative

The investigation was completed on 2/17/2021.It was reported that a female patient (65 year old, 82kg,180cm) underwent cardiac ablation procedure for cardiac ablation with thermocool® smart touch¿ bi-directional navigation catheter and suffered medical device entrapment requiring surgical intervention.Product investigation under (b)(4): only the tip area of the device was received.Therefore, the tip was visually inspected an no internal components were found exposed.The tip area was found in good condition.The tip area was measured and passed the outer diameter test.There was no evidence that the tip area was related to the adverse event.It was not possible to perform a manufacturing record evaluation as the device was not received, only the tip area and the lot number was not available.The customer complaint cannot not be confirmed.It was not possible to analyze the device since we only received the tip area and it evidence was not found in the tip area that is related to the adverse event.Two tips were received at the biosense webster, inc.Analysis lab and clarification was requested to the customer; however, no response was received.Therefore, (b)(4) was created to investigate the second tip received.Product investigation under (b)(4).This pi was created to investigate the second tip received since no response was received by the customer.The tip received was visually inspected and no internal components were found exposed.The tip area was found in good condition.The tip area was measured and passed the outer diameter test (2 diameters were not possible to be measure).There was no evidence that the tip area was related to the adverse event.It was not possible to perform a manufacturing record evaluation as the device was not received, only the tip area and the lot number was not available.The customer complaint cannot not be confirmed.It was not possible to analyze the device since we only received the tip area and evidence was not found in the tip area that is related to the adverse event.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: THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10708689
• MDR Text Key: 212507510
• Report Number: 2029046-2020-01513
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Weight: 82