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

Model Number	D-1201-17-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	04/19/2017
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.Concomitant products: st.Jude medical brk 71cm transseptal needle, lot number unknown; st.Jude medical sl2 8 fr sheath, lot number unknown.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for atrial fibrillation with a navistar ds catheter and suffered a cardiac tamponade requiring pericardiocentesis with pericardial drain.During ablation phase, after some ablation was performed, the patient became hypotensive and a tamponade was detected.Pericardiocentesis yielded an unspecified amount of fluid.Remainder of procedure was aborted.Patient was reported to be in stable condition.Pericardial drain was left in place overnight.Patient required extended hospitalization (1 additional day) as a result of the adverse event.Patient fully recovered with no residual effects.Factors cited that may have contributed to the adverse event include the patient¿s small body habitus.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Transseptal puncture was performed with a st.Jude medical brk 71 cm transseptal needle.Sheath used was a st.Jude medical sl2 8 french.Generator parameters included temperature control mode at 55 degrees celsius, power at 50 watts, and 40 seconds.Average temperature was 53.2 degrees celsius and impedance was 99 ohms.Power was titrated within 5 seconds.Generator settings at the time of injury were not reported, as the physician is uncertain regarding when the injury occurred.At the time of ablation # 51, blood pressure decreased, ablation was stopped, and pericardiocentesis was performed.Overall ablation time at the site of injury was 1777 seconds.Last ablation cycle time at the site of injury was 8 seconds.No irrigated catheter was used during the procedure.Patient received anticoagulant during the procedure with activated clotting times maintained between 300-350 seconds.No error messages presented on any bwi equipment during the procedure.

• Brand Name: NAVISTAR 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: 6557102
• Report Number: 9673241-2017-00368
• Device Sequence Number: 13638091
• Product Code: OAD
• UDI-Device Identifier: 10846835000580
• UDI-Public: (01)10846835000580(11)161019(17)190930(10)17598277M
• Combination Product (Y/N): N
• PMA/510(K) Number: P010068
• 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): 04/19/2017

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: 09/30/2019
• Device Model Number: D-1201-17-S
• Device Catalogue Number: NS7TCD8L174HS
• Device Lot Number: 17598277M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/10/2017
• 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: 65 YR
• Patient Weight: 43