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

Catalog Number	500101
Medical Device Problem Codes	Material Separation (1562); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical spec received a call from uab mcs coordinators (b)(4) regarding accidental disconnection on left side cannula resulting in a low pressure alarm but no drop in cardiac output.They immediately reconnected the driveline and replaced the zip ties.Reported they had to cut off the old zip tie and it appeared to have the grooves worn off.They kept that zip tie and will be returning it.Patient was startled, but awake and stable during event.Spoke with maria after and requested pictures which are attached.Appears zip ties may not have been placed correctly.
Event or Problem Description
Clinical spec received a call from uab mcs coordinators emily and sam regarding accidental disconnection on left side cannula resulting in a low pressure alarm but no drop in cardiac output.They immediately reconnected the driveline and replaced the zip ties.Reported they had to cut off the old zip tie and it appeared to have the grooves worn off.They kept that zip tie and will be returning it.Patient was startled, but awake and stable during event.Spoke with maria after and requested pictures which are attached.Appears zip ties may not have been placed correctly.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that the 70cc tah l/n 123291 and associated cannulae were inspected prior to shipment and no anomalies were found and all manufacturing was performed to specifications.Visual inspection of external components found the zip tie returned had been cut so it was not possible to see how tight it was holding.The portion of the strap that was contained in the locking head could only be moved by ratcheting it in the tightening direction, indicating that the grooves were intact and being held by the locking head.Testing included investigation of the provided pictures of the cannula and zip tie placement as well as consulting clinical support and operator manual review.It was determined that the second zip tie was placed just below the cpc connector and was not making a secure connection.The operator manual indicated that the cpc connectors are installed and zip ties placed at the customer site.It is likely that the misplacement of the zip tie lead to the accidental disconnection of the left cannula.Failure investigation for this complaint confirmed the reported issue.The customer complaint was not replicated during testing due to the specific components returned; the root cause of the reported disconnection of the left cannula was determined to be an incorrectly installed zip tie.Failure investigation identified no test failures or damage that could have contributed to the event.Cannula was immediately reconnected and zip tie was replaced after the disconnection occurred.Patient was reportedly startled but stable throughout the reconnection process.No other adverse impact to patient was reported.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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 18035669
• Report Number: 3003761017-2023-00148
• Device Sequence Number: 7259559
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/11/2025

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: Health Professional
• Device Catalogue Number: 500101
• Device Lot Number: 123291
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 02/12/2025
• 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: 59 YR
• Patient Sex: Male