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 Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) did not crimp properly in the loading device.It did not fold and properly set itself in the deployment device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on 21sep2020 and investigated on 25sep2020.Signs of clinical use and no evidence of blood were observed.There was no blood in or on the delivery tube.The delivery device, and seal- tension spring assembly were returned inside the loading device.The tension spring and seal remained inside the loading device, when the delivery device was pulled out.The white plunger on the delivery device remained not pressed in and the blue lock remained in the locked position.The seal was then pulled out from the loading device for inspection.Microscopic inspection showed the tether remained uncut and attached to the seal and tension spring.No crack/delamination of seal was observed.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.198 inches, the outer diameter was measured at 0.220 inches (rm2036883).The length of the delivery tube was measured at 2.500 inches.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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) did not crimp properly in the loading device.It did not fold and properly set itself in the deployment device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 10613262
• MDR Text Key: 209384456
• Report Number: 2242352-2020-00849
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25150723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 91