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	08/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported as reported summary: when the physician was about to start ablating after sound merge at ra, bb, and sound merge at la, the pericardial effusion was confirmed by soundstar catheter.The drop of blood pressure and the abnormality of ecg were not observed, and pericardial effusion was not observed obviously by transthoracic echo too.Considering the worst case, however, the procedure was ended and the patient left room.

• 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: 6878635
• Report Number: 2183787-2017-00104
• Device Sequence Number: 18863207
• Product Code: DYB
• UDI-Device Identifier: 00846835012388
• UDI-Public: (01)00846835012388(17)180110(10)X3626940
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/08/2017

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: 01/10/2018
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: X3626940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/20/2017
• 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