MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2022

Event Type  Injury  

Event Description

The customer, a syncardia certified hospital, reported that the patient noticed some moisture in his cannula while taking a shower and then noticed a tear on the right cannula at the end of the velour covering.The patient was instructed to go to (b)(6).While at the er, the patient stated his cannula had been like this for "weeks".The patient also stated that the freedom driver did not alarm during the previous weeks.There was no reported clinical adverse patient impact, however, due to the brittleness of the cannulae, the patient was admitted to the hospital.He was released after the cannula was repaired.(the patient is currently under the care of (b)(6) medical center in (b)(6) however, he has chosen to live in (b)(6) which is the reason (b)(6) instructed him to go to (b)(6).(b)(6) was the patient¿s implanting hospital.).

Manufacturer Narrative

While at atrium health, the er staff chose to temporarily closed the cannula tear with bone wax and then rescue tape was wrapped on the entire length of both cannulae.He remained at (b)(6) until the evening of (b)(6) 2022 when he was airlifted to (b)(6).On (b)(6) 2022, the patient¿s cannulae were repaired by his physician.The physician cut the cannulae at the location where the velour ends; he added a 3-stage connector and extended the cannula with new material.Despite asking for the cannula to be returned to syncardia, the bedside nurse threw the cannula into the hazardous waste trash.The physician reported that the cannulae were both very hard and not at all malleable.The 70cc tah-t cannulae were not returned to syncardia for evaluation.Images supplied by the customer and syncardia dir.Of n.A.Distribution and clinical education were reviewed.The tear of the right cannula at the end of the velour was confirmed, however specific dimensions and the nature of this tear remain unknown.It is suspected to have occurred from general wear and tear, and supplemented by the poor overall state of the cannula due to improper care and patient non-compliance.The root cause of a typical cannula tear, as determined in previous investigations, is caused by general wear of the cannula moving and are generally circumferential in direction.With review performed on images received, it was clearly evident that the cannulae were indeed discolored, however the brittleness and malleability could not be confirmed without a physical sample.The investigation was also unable to confirm the reported issue of moisture in the cannulae, as there was also no apparent evidence of moisture in either of the cannula in the provided images.Syncardia has a corrective and preventive action (capa) to address preventive actions for cannula tears.Syncardia has completed its investigation and is closing.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: 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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 15272244
• MDR Text Key: 298380519
• Report Number: 3003761017-2022-00071
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 500101
• Device Lot Number: 110942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male