MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMART TOUCH BIDIRECTIONAL SF CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 (b)(6) female patient ( (b)(6), 62inches) underwent an atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf catheter.The patient suffered pulmonary vein stenosis.The patient was being followed up from a procedure that was performed on (b)(6) 2022 and it was discovered by ct scan the patient had developed pulmonary vein stenosis.The patient is stable and it is unknown if they will require intervention.This adverse event was discovered post use of biosense webster products.The stenosis was discovered during follow up ct scan.The physician¿s opinion on the cause of this adverse event is that it was the procedure and patient condition; the lipv was small and slit like.The patient outcome of the adverse event is worsened, they are short of breath and scheduled for pv stenting.The patient did not require extended hospitalization because of the adverse event.Relevant tests: ct scan.A smartablate generator was used in the event.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or 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.

• Brand Name: SMART TOUCH BIDIRECTIONAL SF 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14267988
• MDR Text Key: 290558294
• Report Number: 2029046-2022-00925
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG