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

Model Number HST III SYSTEM (4.3MM)

Device Problem Fitting Problem (2183)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Related to (b)(4).The hospital reported that during a coronary artery bypass procedure using hst iii system (4.3mm).They were loading the device to prep for surgeon use but the heartstring stayed inside the loading device during step 4.They opened another one to complete the case.There were no patient effects.

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 mode.Historical data analysis: (4109/213/67)there were 1 additional similar complaint reported for the reported failure mode and the reported lot/serial number.A review of the product complaint trend data was performed for the months of ¿aug 2021 ¿ through ¿nov 2021¿.The review does not identify an increasing trend or an adverse trend for three consecutive months for the product family and the 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 to the factory for evaluation on 11/22/2021.An investigation was initiated on 03/11/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger partially depressed and the blue safety lock off, which allows the white plunger to be depressed.The seal was visible in the loading device window.The delivery device was removed from the loading device with no physical or visual difficulties.The seal and tension spring assembly was in the delivery device with the seal in an unopened state.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties.There were no visual defects observed on the seal, no cracks or delamination was observed.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 (rm2036883).The length of the delivery tube was measured at 2.50 inches (mcv00004217).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 not confirmed but was confirmed for the analyzed failure "premature deployment.".

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: 12954722
• MDR Text Key: 285620584
• Report Number: 2242352-2021-01014
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• 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: 03/17/2022

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: 05/26/2022
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25158488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 104 KG