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

Model Number HST III SYSTEM (4.3MM)

Device Problem Crack (1135)

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

Event Date 09/22/2021

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 inspection of the seal, it was noticed that there was a crack in the coil of the hst iii system (4.3mm).The product never entered the surgical field.They got a new heartstring out to complete the case.No patient involvement.

Manufacturer Narrative

Updated section: d-10, g-4, g-7, h-2, h-10, h-11.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id (b)(4).

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/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 number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct-2019 through sept-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 10/21/2021.An investigation was conducted on 11/02/2021.Signs of clinical use and no evidence of blood was observed.The delivery device was observed inside the loading device with the seal observed in the loading device window.The seal and tension spring assembly were observed loaded in the delivery tube, with the seal in a folded taco position and partially load in the delivery tube.The tension spring assembly was removed from the delivery device with no physical or visual defects observed.The seal was observed in the delivery device.The white plunger was not depressed and the blue slide lock was not engaged.The tension spring assembly was removed from the delivery device with no physical or visual defects observed.The tension spring assembly was observed to be intact.The seal was observed to have a crack on the outer two rings of the seal.No other visual defects were observed.The following measurements were taken; the inner delivery tube diameter was measured at.196 in.The outer diameter was measured at.218 in.((b)(4)).The length of the delivery tube was measured at 2.50 in.(b)(4)).Based on the returned condition of the device, the reported failure "crack; seal" was confirmed.

• 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: 12681022
• MDR Text Key: 277902644
• Report Number: 2242352-2021-00851
• 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,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25157571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1