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

Model Number	D-1183-05-S
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	02/13/2017
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.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) male patient underwent an ablation procedure for paroxysmal supraventricular tachycardia (psvt)/atrioventricular reentrant tachycardia (avrt) with a navistar catheter and suffered a heart block av third degree requiring cardiac pacemaker insertion.Initially, ablation was being performed on the right atrial septum, but the physician was unable to eliminate the pathway.When the navistar catheter was changed from the d curve to the b curve and moved to a different location, a heart block occurred.Physician proceeded with the case.Cs catheter was replaced.Ablation was conducted in the left atrium and then the right atrium again.Physician was unable to completely eliminate the bundle of kent.Patient went into complete av block and the procedure ended.Intervention was a temporary external pacemaker.Patient scheduled for a permanent pacemaker to be implanted 3 days post-procedure.Patient required extended hospitalization for cardiac pacemaker implantation.Patient outcome is unchanged.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related and not related to bwi products.

• 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: 6387043
• Report Number: 9673241-2017-00187
• Device Sequence Number: 10876274
• Product Code: DRF
• UDI-Device Identifier: 10846835008531
• UDI-Public: (01)10846835008531(11)160411(17)190331(10)17453130M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990025
• 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
• Report Date (Section B): 02/14/2017

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: 03/31/2019
• Device Model Number: D-1183-05-S
• Device Catalogue Number: NS7TCBL174HS
• Device Lot Number: 17453130M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/08/2017
• 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; Required Intervention
• Patient Age: 48 YR