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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE; INTRODUCER, CATHETER
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GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, SMALL CURVE; INTRODUCER, CATHETER Back to Search Results
Model Number 1000182-001
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Tamponade (2226)
Date of Event 01/04/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that cardiac tamponade occurred during the mapping phase of the procedure.The catheter used for mapping was the pentaray, and before ablating, the catheter went back to the right atrium.It is suspected that the tamponade occured when manipulating the sheaths to try to reach the left atrium again.The procedure was stopped and all catheters removed from the heart.Pericardiocentesis was performed to drain the blood and patient became stable.
 
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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 Key7230726
Report Number2183787-2018-00005
Device Sequence Number1342747
Product Code DYB
UDI-Device Identifier00846835012388
UDI-Public00846835012388
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K130559
Number of Events Summarized1
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) 01/08/2018
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 Date08/10/2018
Device Model Number1000182-001
Device Catalogue NumberD140010
Device Lot NumberX3885262
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/08/2018
Initial Report FDA Received Date01/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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