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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER SUTURE PASSER NEEDLE

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CAYENNE MEDICAL QUATTRO SUTURE PASSER SUTURE PASSER NEEDLE Back to Search Results
Lot Number 64830-1
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/11/2018
Event Type  Injury  
Event Description
The tip of the cayenne quattro suture passer needle broke off inside the pt while in use during surgery. The single piece of the broken tip was successfully completely recovered from the pt immediately following the incident. The original packaging from the broken suture passer needle was saved for reference.
 
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Brand NameQUATTRO SUTURE PASSER
Type of DeviceSUTURE PASSER NEEDLE
Manufacturer (Section D)
CAYENNE MEDICAL
scottsdale AZ 85260
MDR Report Key7731266
MDR Text Key115556043
Report NumberMW5078689
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number64830-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/27/2018 Patient Sequence Number: 1
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