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

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.

• 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 Key: 7582723
• MDR Text Key: 110591120
• Report Number: 3006108336-2018-00008
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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 Date: 12/12/2019
• Device Model Number: N/A
• Device Catalogue Number: CM-9011
• Device Lot Number: 60529-1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR