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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
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ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP Back to Search Results
Model Number IMPELLA CP
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 03/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was discarded by the hospital.No device evaluation can be completed.
 
Event or Problem Description
The physician reported that the patient experienced bleeding issues at the groin after insertion.The physician managed the bleeding with protamin and pressure dressing.
 
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Brand Name
IMPELLA CP
Common Device Name
TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
Manufacturer (Section D)
ABIOMED, INC.
22 cherry hill drive
danvers MA 01923
MDR Report Key7441254
Report Number1220648-2018-00039
Device Sequence Number1540189
Product Code OZD
UDI-Device Identifier00813502011258
UDI-Public00813502011258
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P1400003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2018
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 Physician
Device Expiration Date11/30/2019
Device Model NumberIMPELLA CP
Device Catalogue Number0048-0002
Device Lot Number1324054
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/20/2018
Initial Report FDA Received Date04/18/2018
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;
Patient Age63 YR
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