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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative
Customer indicated that device will be returned for evaluation. Once device is received and evaluated, a follow up report will be submitted to relay any additional information.
 
Event Description
It was reported that device fractured during surgery and remained in patient. Significant surgical delay was reported for this event. No other patient harm was reported for this event.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceNEEDLE
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd street
scottsdale, AZ 85260
4805023661
MDR Report Key10537416
MDR Text Key207048823
Report Number3006108336-2020-00024
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2022
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number71570-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/15/2020 Patient Sequence Number: 1
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