MAUDE Adverse Event Report: ARDEN HILLS, MN VIKING¿ SOFT TIP FIXED CURVE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M0044005040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported tamponade occurred.A viking soft tip diagnostic catheter was selected for use during an atrioventricular nodal reentry tachycardia procedure with cryoablation.Pressures ¿looked good¿ during the 30-minute post ablation waiting phase while the patient was in the room; however, the patient went hypotensive and tamponade occurred about 15 minutes after the patient was brought to recovery.Tamponade was diagnosed via ultrasound; the location of tamponade was unknown.Fluid was removed from the pericardial space and the patient was stable.

• Brand Name: VIKING¿ SOFT TIP FIXED CURVE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• MDR Report Key: 7690216
• Report Number: 2134265-2018-06184
• Device Sequence Number: 16398491
• Product Code: DRF
• UDI-Device Identifier: 08714729879039
• UDI-Public: 08714729879039
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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 Model Number: M0044005040
• Device Catalogue Number: 400504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/16/2018
• 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