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

Model Number 1000182-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Type  Injury  

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis, mn
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, mn ; 9518115
• MDR Report Key: 10407333
• MDR Text Key: 202890169
• Report Number: 2183787-2020-00079
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00821329400995
• UDI-Public: (01)00821329400995(17)210116(10)GB5218221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention