MAUDE Adverse Event Report: GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE; INTRODUCER, CATHETER

Model Number	1000182-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after going transeptal but before ablation the patient's blood pressure dropped slightly and a pericardial effusion was noted.A pericardial effusion was performed and the case was continued.The mobicath steerable sheath was used as part of this procedure.The following bwi devises were also in use: stsf, carto, and smart ablate generator.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 6257666
• Report Number: 2183787-2017-00002
• Device Sequence Number: 899670
• Product Code: DYB
• UDI-Device Identifier: 10846835012385
• UDI-Public: (01)10846835012385(17)170310(10)W3379647
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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: 03/10/2017
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: W3379647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/17/2017
• 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: Required Intervention