MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	D-1260-04-S
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Complete Heart Block (2627); No Code Available (3191); Pericardial Effusion (3271)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Concomitant products: carto 3 system, model # m-4800-01, s/n: (b)(4).(b)(4).
Event or Problem Description
It was reported that a female patient, in her (b)(6), underwent an ablation procedure for atrial flutter with an ez steer navigational ds catheter and suffered heart block av third degree requiring surgical intervention (cardiac catheterization with right coronary artery stent).During ablation, after the first drag lesion was performed, the atrial flutter broke and sinus rhythm was restored.After the second drag lesion was performed, the patient became bradycardic and hypotensive.Echocardiogram confirmed that there was no pericardial effusion.At this point, the patient was in complete heart block and the physician began pacing with the catheter.Patient was sent to the cath lab for cardiac catheterization and a right coronary artery stent.At the time of complaint report, the patient had a temporary pacemaker and a wire.It was noted that the event was temporarily life-threatening.There is no confirmation regarding extended hospitalization, although it is believed that the patient was kept in the hospital after stent placement.Patient was reported to be in stable condition.Physician did not provide a causality opinion.It was noted that the physician would have likely assessed this event as procedure-related.There were no reports of malfunction of any bwi equipment or products.
Additional Manufacturer Narrative
(b)(4).It was reported that a female patient, in her late 50s or early 60s, underwent an ablation procedure for atrial flutter with an ez steer navigational ds catheter and suffered heart block av third degree requiring surgical intervention.The returned device was visually inspected and found in normal condition.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility, and it was found within specifications.A deflection test was performed and the catheter passed.The catheter was also evaluated for functionality on the carto 3 system.The catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.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.The catheter passed all specifications.The root cause of the heart block remains unknown.

• Brand Name: EZ STEER NAV DS
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 5818304
• Report Number: 9673241-2016-00451
• Device Sequence Number: 18992473
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(11)160415(17)190331(10)17452326M
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• 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,Followup
• Report Date (Section B): 06/30/2016

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: 03/31/2019
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17452326M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2016
• Supplement Report FDA Received Date: 08/17/2016
• 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: Required Intervention