MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).After it was placed in the aorta, the wire bow / tension spring was found to be disconnected from the rest.The tether was not in the heartstring seal.As a result, it could not be used for the anastomosis.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period jan-2020 through dec-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/13/22) the device was returned to the factory for evaluation on 02/08/2022.An investigation was conducted on 02/22/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the unraveled seal which indicates an attempt was made to introduce the device into the aorta.The seal was observed to be disconnected from the tension spring assembly.The blue string was observed to be intact.A visual inspection was conducted.Only the seal and tension spring assembly was returned for evaluation.Signs of clinical use and evidence of blood was observed on the unraveled seal which indicates an attempt was made to introduce the device into the aorta.The unraveled seal was observed to be disconnected from the tension spring, with the blue string intact.No other visual defects were observed.Based on the returned condition of the device and the evaluation results, the reported failure "break; seal" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).After it was placed in the aorta, the wire bow / tension spring was found to be disconnected from the rest.The wire hanger with the thread was not connected to the rest.The tether was not in the heartstring seal.As a result, it could not be used for the anastomosis.

Manufacturer Narrative

Corrected section: b1: adverse event/product problem from "adverse event & product problem" to "product problem"; h-2 type of reportable event from "serious injury" to "malfunction"; h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

• Brand Name: HST III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 13176356
• MDR Text Key: 283388685
• Report Number: 2242352-2022-00048
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25160653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention