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	08/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: this was the third session of af ablation.After creation of la voltage map and roof ablation, the physician ablated mitral isthmus from la endocardium with using mobicath sheath.The block line was not completed, so the physician ablated mitral isthmus broadly.The cs potential was not split, and the physician ablated from cs.After that the physician ablated from la endocardium again, then the blood pressure dropped down and pericardial effusion was found by body surface echo.The cardiac drainage was performed with arterial blood, but the perforated site was unknown.This made the patient recover, so the patient was back to hospital 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: 6878702
• Report Number: 2183787-2017-00105
• Device Sequence Number: 16174247
• Product Code: DYB
• UDI-Device Identifier: 00846835012388
• UDI-Public: (01)00846835012388(17)180501(10)X3737363
• 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,Followup
• 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: 05/01/2018
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: X3737363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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