MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAVIGATION; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30498821m number, and no internal action related to the complaint was found during the review.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 or Problem Description
It was reported that a male patient underwent a premature ventricular contraction (pvc) ablation procedure with a ez steer¿ thermocool® nav bi-directional catheter.The patient suffered complete heart block requiring indwelling icd to have pacer settings activated.During ablation the patient had av block.The patient originally had an icd, and we put v pace.The patient originally had an icd and left the room with a ddd setting with a v-pace.The physician commented that when ablation was done, the catheter jumped.Additional information: they said it remained 8/3 complete.The patient was originally implanted with an icd and v pacing was added.The adverse event occurred during use of bwi products.The patient's condition was reported as having improved.Since this event is life threatening and required interventions to prevent permanent impairment of a body function or permanent damage to a body structure, then is to be considered serious and mdr-reportable.

• Brand Name: EZ STEER THERMOCOOL NAVIGATION
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12322691
• Report Number: 2029046-2021-01346
• Device Sequence Number: 4173210
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30498821M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTARAY NAV; SMARTABLATE GENERATOR; PENTARAY NAV; SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention