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

Model Number HST III SYSTEM (3.8MM)

Device Problem Fitting Problem (2183)

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

Event Date 09/03/2021

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).They were loading the heartstring for use, following the loading instructions as indicated.The heartstring seal did not come out of the loading device during step 4, however, but remained in the loading device instead.Another heartstring was opened for use and that one loaded properly.The hospital did not report any patient effects.

Manufacturer Narrative

(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.

Manufacturer Narrative

Trackwise id#: (b)(4).Updated sections: b-4, g-4, g-7, h-2, h-3, h-6,h-10.Analysis of production: (3331/213 & 67) the device history records review concluded that there were ncmrs but no relation for the reported lot/serial 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/serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period dec -2019 through nov-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 /213 & 67) the device was returned to the factory for evaluation on 11/22/2021.An investigation was initiated on 03/11/2022.A visual inspection was conducted.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety lock was on, which prevents the white plunger from not being depressed.The seal was observed in the loading device body.Signs of clinical use and no evidence of blood was observed.The delivery device was removed from the loading device with no physical or visual difficulties.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties observed.There were no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.198 inches, the outer diameter was measured at 0.221 inches ((b)(4)).The length of the delivery tube was measured at 2.50 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.

• 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: 12956497
• MDR Text Key: 286446517
• Report Number: 2242352-2021-01022
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25154862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 83 KG