MAUDE Adverse Event Report: CAYENNE MEDICAL, INC. QUATTRO SUTURE NEEDLE

Model Number CM-9011

Device Problem Device Issue (2379)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

Quattro suture passer needle tip broke during a rotator cuff repair procedure.The broken tip was left in the patient.The remainder of needle was not returned to cayenne medical for evaluation.When penetrating very thick tissue, the tip of the needle could be potentially diverted from its travel path and hit the top jaw of the passer instead of the trap door of the passer.As a result, this could damage the needle ti and cause breakage as reported.Complaint record (b)(4) was opened to investigate this incident.It should also be noted that it was reported that the breakage might have been due to user error.

Event Description

Quattro suture passer needle tip broke off during a rotator cuff repair procedure.On (b)(6) 2015, it was reported to cayenne medical product manager that the broken tip was not retrieved and was left in the patient.It was also reported that the surgeon was not sure if the breakage was due to user error as the needle might have hit the acromion or to suture passer/needle malfunction.Another cayenne medical suture passer needle was used to finish the repair procedure.

• Brand Name: QUATTRO SUTURE NEEDLE
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): CAYENNE MEDICAL, INC.; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85255
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; scottsdale 85260 ; 4805023661
• MDR Report Key: 5250870
• MDR Text Key: 32304766
• Report Number: 3006108336-2015-00005
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/30/2018
• Device Model Number: CM-9011
• Device Catalogue Number: CM-9011
• Device Lot Number: 54396-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention