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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 12/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that after an afib case, a pericardial effusion was confirmed and found through intracardiac ice.Caller reported that the medical intervention provided was pericardiocentesis and 200 cc's were removed.The patient's condition is 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 Key7859862
Report Number2183787-2018-00068
Device Sequence Number1337402
Product Code DYB
UDI-Device Identifier00821329400995
UDI-Public00821329400995
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 08/23/2018
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 Date08/09/2018
Device Model Number1000182-001
Device Catalogue NumberD140010
Device Lot NumberVN3880858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2018
Initial Date Received by Manufacturer 08/23/2018
Supplement Date Received by Manufacturer08/23/2018
Initial Report FDA Received Date09/10/2018
Supplement Report FDA Received Date10/25/2018
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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