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

Catalog Number	NS7TCD8L174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacture record evaluation (mre) cannot be conducted because no lot number was provided by the customer.(b)(6).Manufacturer's reference #: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a navistar¿ ds electrophysiology catheter and suffered acute myocardial infraction requiring cardiac massage.Immediately after ablation for at near the his bundle from the aorta, the patient¿s hemodynamics was compromised.Cardiac massage was performed, and the patient recovered.The procedure was completed.There¿s no information regarding extended hospitalization.Patient¿s outcome and physician causality opinion are unknown.No bwi product malfunctions were reported.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
Additional Manufacturer Narrative
On 9/2/2019, biosense webster received additional information about the event.It was reported that no surgical intervention was needed and the patient received ¿heart massage on the spot¿ meaning chest compression (cardiac massage) on the skin, not open chest.Manufacturer¿s ref # (b)(4).
Additional Manufacturer Narrative
On 8/13/2019, bionsense webster inc.Received additional information indicating the that physician did not provide an opinion regarding the causality of the event.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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8773520
• Report Number: 2029046-2019-03397
• Device Sequence Number: 11404613
• Product Code: OAD
• UDI-Device Identifier: 10846835000580
• UDI-Public: 10846835000580
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: NS7TCD8L174HS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 09/02/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/19/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention