MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	D-1183-08-S
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a ventricular tachycardia ablation procedure for premature ventricular contractions (pvcs) with a navistar catheter and suffered a cardiac tamponade (no intervention reported) and cardiac arrest (requiring cardiopulmonary resuscitation).During ablation phase, 3 minutes after the last ablation, the patient became hypotensive and a tamponade was confirmed via transthoracic echocardiogram.Patient arrested and cardiopulmonary resuscitation was initiated and patient was intubated.Patient was reported to be in stable condition.Patient required extended hospitalization as a result of this adverse event.Patient outcome is improved.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure.Transseptal puncture was not performed.No sheath information was reported.Generator parameters at the time of injury included temperature control mode with temperature cut-off at 50 degrees celsius and power cut-off at 50 watts (not titrated).Overall ablation time at the site of injury was approximately 3-5 minutes.Last ablation cycle time at the site of injury was 45 seconds.No irrigated catheter was used during the procedure.Patient received anticoagulant (heparin 4000 units) during the procedure with activated clotting times of 158 and 168 seconds.There were no errors reported on any bwi equipment during the procedure.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6231370
• Report Number: 9673241-2017-00028
• Device Sequence Number: 393621
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: (01)10846835000610(11)160809(17)190731(10)17543792M
• Combination Product (Y/N): N
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: 07/31/2019
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17543792M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/06/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 98