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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO DEVICE, PERCUTANEOUS, BIOPSY
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MEDTRONIC MEXICO DEVICE, PERCUTANEOUS, BIOPSY Back to Search Results
Catalog Number VPB11
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/30/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent bone biopsy of the iliac crest.Intra-op, the radiologist advanced the bone biopsy into the iliac lesion and the purple part of the stylet broke-off.The product came in contact with patient.There was a delay in overall procedure.No patient complications were reported as a result of this event.
 
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Brand Name
DEVICE, PERCUTANEOUS, BIOPSY
Common Device Name
DEVICE, PERCUTANEOUS, BIOPSY
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key8745965
Report Number9612164-2019-02593
Device Sequence Number14924977
Product Code MJG
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Type of Report Initial
Report Date (Section B) 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberVPB11
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/30/2019
Initial Report FDA Received Date06/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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