MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER GT

Model Number N/A

Device Problems Misfire (2532); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Customer has indicated that the device will be returned for evaluation.Once the investigation is complete, a supplemental will be filed accordingly.

Event Description

It was reported that quattro suture passer gt device malfunctioned causing needles to break inside the suture passer during surgery.Another device had to be requested to complete the surgery causing surgical delay of 70 minutes.No other patient harm was reported.

Manufacturer Narrative

This report is being submitted to relay additional information.Device was not returned to the manufacturer for evaluation.Dhr was reviewed, and no related anomalies were noted.If additional information was received, a follow up report will be submitted.Cayenne will continue to monitor for future events.H3 other text : device not returned.

Event Description

It was reported that quattro suture passer gt device malfunctioned causing needles to break inside the suture passer during surgery.Another device had to be requested to complete the surgery causing surgical delay of 70 minutes.No other patient harm was reported.

• Brand Name: QUATTRO SUTURE PASSER GT
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• MDR Report Key: 9341084
• MDR Text Key: 166972196
• Report Number: 3006108336-2019-00075
• Device Sequence Number: 1
• Product Code: NBH
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9010GT
• Device Lot Number: 3470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention