MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number	500101
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, patient's blue cannula had a crack by the cpc connector.The cpc connector was changed out by removing part of the cannula with a wire cutter.Patient reportedly tolerated the repair well.Rescue tape was placed around the cannulas post repair.
Event or Problem Description
Per hospital staff, patient's blue cannula had a crack by the cpc connector.The cpc connector was changed out by removing part of the cannula with a wire cutter.Patient reportedly tolerated the repair well.Rescue tape was placed around the cannulas post repair.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that 70cc tah lot# 126590 passed inspection without any anomalies with all components up to specification prior to implant.Visual inspection of external components found that the right cannula piece returned to manufacturer for investigation found a circumferential tear spanning approximately 50% around the circumference of the cannula.Photographic evidence confirmed the crack was repaired and area of cannula returned included the entirety of the cracked surface.There is no functional testing for the torn cannula.This is a known material integrity issue that is currently being addressed under a capa.It is undiscernible if the tear, at the time of repair, led to a loss of pressure (tearing through the whole cannula wall) or not (did not tear through the whole cannula wall).The piece that syncardia received is torn all the way through the cannula wall.Failure investigation for this complaint confirmed the reported issue during visual inspection.The root cause of the reported cannula tear was determined to be the change in the effective stiffness of the cannula at the junctions of the velour/cannula junction and the driveline/cannula junction.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Cannula tears are a known issue that are currently being addressed via capa.Cannula was repaired in hospital without issue and with no reported adverse impact to patient.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• Brand Name: SYNCARDIA 70CC TAH
• Common Device Name: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 18529553
• Report Number: 3003761017-2024-00056
• Device Sequence Number: 18039103
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 500101
• Device Lot Number: 126590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male