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

Model Number	D-1336-03-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	11/10/2016
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 medical products: lasso nav variable eco catheter (model# d-1343-01-s lot# 17236098l).(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool® smarttouch® uni-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.At the end of the procedure, during the verification phase, the physician attempted to pass a smarttouch ablation catheter next to the transseptal sheath.The physician had a ¿bad sensation¿ and immediately removed the catheter.Patient quickly became hypotensive.A pericardiocentesis was performed and yielded an unknown amount of fluid.The patient was reported to be in stable condition upon leaving the procedure room.The patient required extended hospitalization as a result of this adverse event for monitoring and has since fully recovered with no residual effects.Factors cited that may have contributed to the adverse event include the patient¿s medical history of valvulopathy with surgical repair several years ago.Physician¿s opinion regarding the cause of the adverse event is that it was related to patient anatomy.It was also noted that the catheter likely tore the septum.Transseptal puncture was performed with a st.Jude medical brk xs transseptal needle.Sheath used was a st.Jude medical swartz sl0 8.5 french.Generator was set on power control mode at 25 watts (with cutoff at 25 watts).Power was not titrated.Temperature cutoff was 47°c.There is no other information regarding generator parameters, overall ablation time, or last ablation cycle time at the site of injury.Irrigated catheter flow was set on 30ml/min.Patient received anticoagulant during the procedure with activated clotting times maintained between 250-300 seconds.There were no errors reported on any bwi equipment during the procedure.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION 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: 6151957
• Report Number: 9673241-2016-00843
• Device Sequence Number: 10982121
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)151112(17)171031(10)17354021M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030031/S053
• 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): 11/14/2016

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-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17354021M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 12/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 YR