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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX CORING REAMER

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CAYENNE MEDICAL APERFIX CORING REAMER Back to Search Results
Device Problem Device Operates Differently Than Expected
Event Type  Injury  
Manufacturer Narrative

This report is being submitted late, due to an internal retrospective review.

 
Event Description

It was reported to cayenne medical that " the guidewire offered with the reamer broke at the tip, then tried to ream, and it took about an hour to pull out the entire piece with a rasp. ".

 
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Brand NameAPERFIX
Type of DeviceCORING REAMER
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd st
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd st
scottsdale , AZ 85260
4804582196
MDR Report Key7104873
Report Number3006108336-2017-00013
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/11/2017 Patient Sequence Number: 1
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