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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE SUTURING NEEDLE, SINGLE-USE

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE SUTURING NEEDLE, SINGLE-USE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign country: (b)(6). It is unknown if the device will be returned for analysis at this time; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the quattro suture passer needle broke during the surgery. There was a 2 minute delay in the procedure to prepare new suture passer with different needle. The procedure was successfully finished with another needle. There was no impact on patient. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceSUTURING NEEDLE, SINGLE-USE
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
scottsdale, AZ 85260
4805023661
MDR Report Key12165813
MDR Text Key261468839
Report Number3006108336-2021-00029
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/02/2021
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number69519-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2018
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: 07/14/2021 Patient Sequence Number: 1
Treatment
912029 JGRKNT 2.9MM #2 SNGL NGLE LOT#P12896; CM-9011 QUATTRO SUTURE PASSER NEEDLE LOT#75957-1
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