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

Catalog Number D133602

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

Patient Problem Inflammation (1932)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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 ref.# (b)(4).

Event Description

During a clinical trial, sponsored by bwi, a (b)(6) year old male underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and pericarditis occurred.It was reported that on the day of the procedure, the patient suffered pericarditis.No intervention was reported.However, extended hospitalization was required.The issue is resolved.The principal investigator assessed this event as anticipated, moderate, not related to study device (visitag surpoint epu), possibly related to study catheters and probably related to the index procedure.

Manufacturer Narrative

On (b)(6)2020 , specific product details such as the part number and lot number were received.As such, the following fields have been updated: d4.Catalog # updated from unk_smart touch bidirectional to d133602.D4.Lot # updated from blank to 30321015m.D4.Expiration date updated from blank to 11/25/2020 d4.Unique identifier( udi) updated from blank to(b)(4).H4.Manufacture date updated from blank to 11/26/2019.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).A manufacturing record evaluation was performed for the finished device 30321015m number, and no internal action related to the complaint was found during the review.Since no device has been received for analysis, no product evaluation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On (b)(6) 2020, biosense webser inc.Received additional information which indicated the relationship of the adverse event of "pericarditis" to study catheter has been reassessed from possible to probable.The relationship to procedure has been reassessed from probable to causal relationship to the index procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9856092
• MDR Text Key: 191593633
• Report Number: 2029046-2020-00444
• Device Sequence Number: 1
• Product Code: LPB
• 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,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Catalogue Number: D133602
• Device Lot Number: 30321015M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR