MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1315-04-S
Health Effect - Clinical Code	ST Segment Elevation (2059)
Date of Event	12/02/2016
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.Concomitant product: pentaray catheter (model# unknown lot# unknown), coolflow irrigation tubing (model# d-1233-18-s lot# unknown), webster 10 pole catheter (model# d-1079-230-s lot# 17523031m).(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for atypical atrial flutter with a thermocool® sf nav uni-directional catheter and thermocool® sf nav bi-directional catheter and suffered an acute myocardial infarction (ami) requiring pacing and cardiac arrest requiring cardiopulmonary resuscitation (cpr) and pharmacologic support.During ablation, st elevation was noted in the inferior leads (ii, iii, and avf).Patient was paced via the ablation catheter in the right ventricular apex.Patient went into cardiac arrest and cpr was initiated and pharmacologic support was provided.Coronary angiogram revealed no pathology.Patient was transferred to the intensive care unit.There is no information regarding extended hospitalization.It was noted that the patient remained in atrial flutter throughout the procedure.The flutter was unaltered by the event or by the ablation procedure at that time.It was also noted that the patient later returned to sinus rhythm.Patient has a history of prior pulmonary vein isolation (pvi) ablation.Physician is uncertain regarding the cause of the adverse event.Physician confirmed that the adverse event was not caused by bwi products.It was also noted that char was observed on the thermocool® sf nav bi-directional catheter approximately 3 hours into the procedure.Catheter was replaced with the thermocool® sf nav uni-directional catheter.It was noted that the irrigation bags were above minimum fluid levels and the pentaray pressure bag was within normal limits.Adverse event occurred approximately 5 minutes after catheter replacement.The charring discovered is not mdr reportable because char is a physical phenomenon of rf and can be the normal result of an ablation process.The presence of char on the electrodes does not represent a serious injury in itself nor is necessarily the result of device malfunction.
Additional Manufacturer Narrative
Incorrect manufacture date and udi number provided in initial 3500a report.Correct manufacture date and udi have been properly updated in the corresponding fields of this report.(b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6215545
• Report Number: 9673241-2016-00919
• Device Sequence Number: 11117368
• Product Code: LPB
• UDI-Device Identifier: 10846835009255
• UDI-Public: (01)10846835009255(11)141114(17)171031(10)17136868L
• Combination Product (Y/N): N
• PMA/510(K) Number: P030031/S034
• 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
• Report Date (Section B): 12/05/2016

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: 10/31/2017
• Device Model Number: D-1315-04-S
• Device Catalogue Number: D131504
• Device Lot Number: 17136868L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/30/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 65 YR