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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no medical record evaluation (mre) review could be performed.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a redo ablation procedure with an unknown thermocool smart touch sf catheter and developed pericarditis requiring medication as intervention.Originally it was reported that after a redo ablation procedure the patient developed pericarditis and no medical or surgical intervention was required.The patient was kept in overnight for monitoring purposes.The issue resolved without sequelae.The principal investigator assessed the event as moderate in severity, serious, unrelated to the study device and possibly related to a repeated study.In the opinion of the investigator, this event was anticipated.On 2/5/2019, additional information was received that the repeat ablation procedure was most probably done with an stsf catheter.However, the catalog and lot # are not available.Since there was originally no evidence that medical intervention, surgical intervention, or prolonged hospitalization was required for treatment, the observed pericarditis was assessed as not mdr reportable.This event is being reported because on 4/12/2019, we received clarification that as a result of the pericarditis, an unspecified medication was administered.The issue of pericarditis requiring medication has been assessed as mdr reportable.The awareness date has been reset to 4/12/2019.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8561643
• MDR Text Key: 143447796
• Report Number: 2029046-2019-03042
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• 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
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR