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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 Pericardial Effusion (3271)
Date of Event 05/04/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that after the second transseptal puncture during an atrial fibrillation procedure the physician noticed a pericardial effusion on the ice catheter.The case was aborted and a pericardiocentesis was performed.The caller stated that the physician was considering sending the patient to surgery at the time of the call.No other information was provided at this time.
 
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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 Key7521578
Report Number2183787-2018-00038
Device Sequence Number1385420
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) 05/07/2018
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 Date12/18/2018
Device Model Number1000182-001
Device Catalogue NumberD140010
Device Lot NumberX4081795
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/07/2018
Initial Report FDA Received Date05/17/2018
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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