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 10/27/2020

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

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

Manufacturer Narrative

(b)(4).The lot # 25154132 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 (b)(6) 2020 and investigated on (b)(6) 2020.Signs of clinical use and evidence of blood were observed.There was blood on the loading device.Delivery device was returned outside loading device.The tension spring and seal remained inside the loading device.The white plunger on the delivery device remained unpressed and the blue lock remained in the locked position.The seal was seen in the loading device, 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 0.199 inches, the outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.50 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) would not load properly.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: 10870304
• MDR Text Key: 217980331
• Report Number: 2242352-2020-01022
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25154132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1