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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE
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SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE Back to Search Results
Catalog Number 500101
Device Problems Physical Property Issue (3008); Torn Material (3024)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
The removed tah-t cannula piece will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer reported that the patient observed a small tear in the 70cc tah-t cannula near the cpc connector.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.
 
Manufacturer Narrative
The removed tah-t cannula piece was returned to syncardia for evaluation.The customer-reported cannula tear was confirmed through physical examination of the returned section of cannula.Similar to other malfunctions observed in the field and previously documented, this tear occurred near the cannula/cpc junction.There are multiple contributing causes of cannula tears.As identified in previous cannula tear investigations, patients supported by portable drivers are more likely to place increased stress on the cannulae.These stresses are concentrated where the effective stiffness of the cannula changes, specifically at the velour/cannula junction and the driveline/cannula junction.The increased stresses at these junctions can lead to a cannula tear.This is caused by the different material behaviors of the pvc cannula material, the stainless steel reinforcing wire, the cpc connector and the cannula velour when placed under flexural, rotational or tensile stresses.Wear occurs at the surface or between pvc layers, eventually leading to tear initiation.Syncardia has an open capa (corrective and 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.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
 
Event Description
The customer reported that the patient observed a small tear in the 70cc tah-t cannula near the cpc connector.The customer also reported that the 70cc tah-t cannula was successfully repaired by the hospital staff.There was no reported adverse patient impact as a result of the cannula tear and subsequent repair.
 
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Brand Name
SYNCARDIA 70CC TAH-T
Type of Device
BIVENTRICULAR REPLACEMENT DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6186694
MDR Text Key63188844
Report Number3003761017-2016-00395
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Catalogue Number500101
Device Lot Number096907-70CC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age35 YR
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