MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problem Premature Activation (1484)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

(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, hst iii system (4.3mm) umbrella triggered too early.Umbrella opened before use.No injury, since no use, no effect on the patient.A new hsk device was used and thus completed.

Manufacturer Narrative

Trackwise # (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 (b)(4).Updated sections: g4, g7, h2, h3, h6, h10.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 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 & testing of raw/starting materials: (10 & 4105/13 & 22) the device was returned for evaluation on 12/08/2021.Photographs were provided by the account.A photographic inspection was conducted.The delivery device was observed in he loading device with the seal and tension spring assembly in the loading device window.There were no visible defects observed on the seal.The white plunger was partially visible in the photographs and was observed to be not depressed.The blue side lock was not observed in the photographs.An investigation was conducted on 12/14/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The delivery device was returned inside the loading device but not lined up with the "2".Blood was observed on the loading device.The white plunger was not depressed and the blue slide lock was not engaged.The seal was observed in the loading device window.No visible defects were observed on the seal.The delivery device was removed from the loading device with the seal and tension spring assembly remaining inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual defects.No cracks or delamination was observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.213 inches.The length of the delivery tube was measured at 2.48 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "premature activation" was not confirmed but was confirmed for the analyzed failure "fitting problem".

Event Description

N/a.

• Brand Name: HST III SYSTEM (4.3MM)
• 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: 12908925
• MDR Text Key: 283607805
• Report Number: 2242352-2021-00996
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• 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: 01/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25158691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/08/2021; 01/26/2022
• Supplement Dates FDA Received: 12/28/2021; 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male