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

Model Number	D-1183-08-S
Health Effect - Clinical Code	Complete Heart Block (2627)
Date of Event	01/24/2017
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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for paroxysmal supraventricular tachycardia (psvt)/atrioventricular nodal reentrant tachycardia (avnrt) with a navistar catheter and suffered a heart block av third degree requiring cardiac pacemaker insertion.During ablation, the patient went into a 2:1 heart block.After a 25 minute waiting period, a permanent pacemaker was implanted.At the time of pacemaker insertion, the patient was in a stable accelerated junctional rhythm.Patient was reported to be in stable condition.Patient required one additional night of hospitalization as a result of this adverse event.Patient fully recovered with no residual effects.Medical history includes juvenile diabetes and anxiety.Physician¿s opinion regarding the cause of the adverse event is that it was not related to any bwi product malfunction.Generator settings included power at 50 watts and temperature at 50 degrees celsius.

• 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: 6330580
• Report Number: 9673241-2017-00118
• Device Sequence Number: 16348127
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: (01)10846835000610(11)160712(17)190630(10)17516824M
• 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): 01/24/2017

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: 06/30/2019
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17516824M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/14/2017
• 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: 38 YR
• Patient Weight: 148