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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 11/12/2020
Event Type  Injury  
Manufacturer Narrative
Customer has indicated the device is being returned for evaluation. Once investigation is complete, additional report will be submitted to relay any additional information.
 
Event Description
It was reported that suture passer needle has fractured during surgery, and the fractured piece remained inside the patient. No other patient harm was reported.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceNEEDLE
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd street
101
scottsdale, AZ 85260
4805023661
MDR Report Key10971976
MDR Text Key220427037
Report Number3006108336-2020-00031
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCM9011
Device Lot Number77372-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/08/2020 Patient Sequence Number: 1
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