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	Cardiac Tamponade (2226)
Type of Reportable Event	Serious Injury
Event or Problem Description
Detailed circumstances at the time of occurrence (always stated if an error code is known): pvi, after cti isolation, when triggered from cs, at occurred during mapping blood pressure dropped, it was checked became cardiac tamponade by echocardiography.During ablation blood pressure did not drop suddenly, it was unknown at what timing it became a dandelion.Timing when complaints occurred: after 3 hours since the procedure was started pvc, after cti isolation, during atmapping how to complete the procedure: performed pericardial drainage.To icu after pericardial drainage.(we will confirm the situation later and report it).The complaint product(s) will not be returned for analysis.No further information is available.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis, mn
• MDR Report Key: 10407333
• Report Number: 2183787-2020-00079
• Device Sequence Number: 2925755
• Product Code: DYB
• UDI-Device Identifier: 00821329400995
• UDI-Public: (01)00821329400995(17)210116(10)GB5218221
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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: 01/16/2021
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Device Lot Number: GB5218221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/14/2020
• 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: Hospitalization; Life Threatening; Required Intervention