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 Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

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.Device not returned.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm), incorrect loading of the device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25153463 history record review was completed.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 batch manufacturing process and the reported failure.The device was returned to the factory for evaluation on 11/04/2020.An investigation was conducted on 11/13/2020.Only the delivery device and the seal and tension spring assembly was returned for evaluation.The delivery device was observed to be intact, no visual defects were observed.The white plunger was not depressed and the blue slide lock was not dis-engaged.The seal and tension spring assembly was observed inside the delivery tube but not in its normal position.The seal and tension spring assembly isn't fully loaded in delivery tube.The seal was observed to be in an open state with the tension spring assembly loaded in the delivery tube.The seal and tension spring assembly was removed from the delivery device.No cracks or delamination was observed on the seal.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at 0.196 inches; the outer diameter was measured at 0.218 inches.The length of the delivery tube was measured at 2.49 inches.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm), incorrect loading of the device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HST 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: 10788512
• MDR Text Key: 214761228
• Report Number: 2242352-2020-00962
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25153463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 74