MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA 70CC TAH-T CANNULA; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Material Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2015

Event Type  malfunction  

Event Description

The customer reported that there is a small tear above the quick release of the 70cc tah-t cannula that is connected to a freedom driver that was supporting a patient.The customer also reported that the 70cc tah-t cannula was successfully repaired.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.This alleged failure mode poses a low risk to the patient because although there was a small tear on the tah-t cannula, the freedom driver continued to perform its life-sustaining functions.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4) : hospital disposed of damaged cannula.

Event Description

The customer reported that there is a small tear above the quick release of the 70cc temporary total artificial heart (tah-t) cannula that is connected to a freedom driver that was supporting a patient.The customer also reported that the 70cc tah-t cannula was successfully repaired.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.The damaged section of the 70cc tah-t cannula was not returned to syncardia for investigation since the customer disposed of the damaged section of cannula.A review of the device history record (dhr), ventricle shop orders, cannula assembly shop orders, and the sterilization work order for the 70cc tah-t confirmed that all manufacturing was performed to specifications and the 70cc tah-t met all specified requirements prior to shipment.As of (b)(6) 2015, the patient currently remains at home on tah-t support with total support duration of 406 days.Syncardia has initiated a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.Per the syncardia freedom driver system guidebook for patients and caregivers - us, end users are instructed to inspect the drivelines and cannulae daily.If a hole is observed in the drivelines or cannulae, household tape must be applied to temporarily repair the hole and the hospital contact person must be contacted to arrange for a hospital-based evaluation.

• Brand Name: SYNCARDIA 70CC TAH-T CANNULA
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5545621
• MDR Text Key: 177975095
• Report Number: 3003761017-2015-00313
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2015
• 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 Age: 47 YR