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

Model Number HST III SYSTEM (3.8MM)

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

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) seal failed to deploy.It was loaded properly but it seal was stuck in the delivery device and didn't come out.The procedure was completed with a new device and there was no patient effect reported.

Manufacturer Narrative

Trackwise#: (b)(4).The lot#: 25150363 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 hsk iii device was returned to the factory for evaluation on 10dec2020.Photograph from the account shows that the delivery device was returned outside the loading device with the seal observed near the delivery window of the loading device.The device was investigated on 21apr2021.Sign of clinical use and no evidence of blood was observed.A visual inspection was conducted.The delivery device was returned outside the loading device with the seal observed near the delivery window.The seal and tension spring assembly remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely pressed on the delivery device.The seal was taken out from the loading device for inspection.There was no sign of crack/delamination on the seal.The following measurements were taken; the inner delivery tube diameter was measured at.198 inches.The outer diameter was measured at.219 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based on the received condition of the device the reported ¿activation problem¿ was not confirmed but confirmed for analyzed failure modes ¿fitting problem¿ and "premature deployment".

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal failed to deploy.It was loaded properly but it seal was stuck in the delivery device and didn't come out.The procedure was completed with a new device and there was no patient effect reported.

• 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: 11028279
• MDR Text Key: 222065649
• Report Number: 2242352-2020-01129
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25150363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 62