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U.S. Department of Health and Human Services

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

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE; SUTURE NEEDLE Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/11/2018
Event Type  Injury  
Event Description
It was reported that "needle tip broke during suture passing.Needle tip could be located under x-ray but could not be removed from the tissue.".
 
Manufacturer Narrative
(b)(4).Device evaluation: the needle was returned for evaluation.The tip of the needle broke at the suture notch.The needle was also buckled at the weld junction.The deformation from the buckling indicated that the needle was stuck, possibly at the tip, to prevent it from advancing forward.Excessive force from the trigger trying to push the needle forward caused the needle to buckle at the weld joint and broke at the tip as a result.It is possible that overstuffing the tissue between the jaws cause the tip of the suture needle to divert from its trajectory path to miss the trap door to hit the top jaw and stuck.It is also possible that the suture passer used in the case had the bottom jaw bent, which cause the tip of the needle to hit other feature of the top jaw and stuck.Since the suture passer used in the case was not returned for the investigation, the exact root cause cannot be determined.
 
Event Description
It was reported that "needle tip broke during suture passing.Needle tip could be located under x-ray but could not be removed from the tissue.
 
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Brand Name
QUATTRO SUTURE PASSER NEEDLE
Type of Device
SUTURE NEEDLE
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
MDR Report Key7582723
MDR Text Key110591120
Report Number3006108336-2018-00008
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/12/2019
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number60529-1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/08/2018
Supplement Dates Manufacturer Received05/11/2018
Supplement Dates FDA Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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