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U.S. Department of Health and Human Services

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

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE NEEDLE, SUTURING Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis, due to the device being discarded; 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 a quattro suture passer needle broke inside of a patient during a shoulder scope. The broken needle was retrained in the patients shoulder. 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 DeviceNEEDLE, SUTURING
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 Key12306818
MDR Text Key265993389
Report Number3006108336-2021-00030
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCM-9011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/11/2021 Patient Sequence Number: 1
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