MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NS7TCF8L174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a navistar¿ ds electrophysiology catheter and suffered a cardiac tamponade requiring a pericardiocentesis.During a typical atrial flutter ablation, an audible steam pop occurred during radiofrequency.Later discovered of lower blood pressure with cardiac tamponade.Pericardial drainage to restore blood pressure at normal levels.Since the event (cardiac tamponade) 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.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.Therefore, steam pop is not mdr reportable.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) during an internal review on 26-jul-2023, it was noted that the previously reported lot number of 34j57m is not a lot number.The reference number of 34j57m is an eu catalog number.Therefore, the lot number for navistar¿ ds electrophysiology catheter is unknown.
Additional Manufacturer Narrative
It was reported that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a navistar¿ ds electrophysiology catheter and suffered a cardiac tamponade requiring a pericardiocentesis.During a typical atrial flutter ablation, an audible steam pop occurred during radiofrequency.Later discovered of lower blood pressure with cardiac tamponade.Pericardial drainage to restore blood pressure at normal levels.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number: 34j57m identified no internal actions related to the reported complaint condition.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER
• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15999685
• Report Number: 2029046-2022-03158
• Device Sequence Number: 5767566
• Product Code: OAD
• UDI-Device Identifier: 10846835000603
• UDI-Public: 10846835000603
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2023

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 Model Number: NS7TCF8L174HS
• Device Catalogue Number: NS7TCF8L174HS
• Device Lot Number: 34J57M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 05/25/2023; 07/26/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 06/23/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown