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

Model Number HST III SYSTEM (3.8MM)

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id #: (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm), loading the closed umbrella into the tube was not possible.The folded (¿closed¿) umbrella did not went properly into the holder (delivery tube).This was clearly seen through the window of the loader.Device was not used in the patient.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm), loading the closed umbrella into the tube was not possible.The folded (¿closed¿) umbrella did not went properly into the holder (delivery tube).This was clearly seen through the window of the loader.Device was not used in the patient.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25149826 history record review was completed.There were ncmrs, rework, or deviations documented for the reported lot number.(ncmr #17111-maquet received complaint number (b)(4) stating during surgery one aortic cutter 3.8mm with lot #25149769 malfunctioned.Customer reported that the aortic cutter cut to wrap around the surrounding tissue resulting in an anastomosis with a diameter of 7mm.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory on 10/20/2020.An investigation was conducted on 10/30/2020.A visual inspection was conducted.While it was reported that there was no patient involvement.Signs of clinical use and evidence of blood was observed on the loading device.The seal was observed in the loading window in an open state.The delivery device was returned inside the loading device.The white plunger on the delivery device was not depressed and the blue slide lock was not disengaged.The delivery device was removed from the loading device with the seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device.The seal and the tension spring assembly was observed to be intact, no cracks or delamination was observed on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.195 inches, the outer diameter was measured at 0.224 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 and evaluation results, the reported failure ¿fitting problem" was confirmed.

• Brand Name: HSK III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10713259
• MDR Text Key: 212348453
• Report Number: 2242352-2020-00919
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25149826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1