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

Model Number HST III SYSTEM (3.8MM)

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The lot # 25153082 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 21dec2020.Photograph from the account shows that the delivery device was seen outside loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.Product was investigated on 28dec2020.Signs of clinical use and no evidence of blood were observed.The delivery device was returned outside loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was then pulled out from the loading device for inspection.The seal did not appear to be folded.There was no sign of crack/delamination on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.198 inches, the outer diameter was measured at 0.219 inches (b)(4).The length of the delivery tube was measured at 2.500 inches (b)(4).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 failures "failure to unfold or unwrap" were not confirmed but the analyzed failure "fitting problem" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly installed in the tube.There is a phenomenon that you can not fall out.The seal deployed properly and failed to unfold.They tried to install it by forcibly removing the seal, but it could not be used because the seal did not come off, so they used the same new product to finish the operation well.The patient was in good condition and the operation was well completed.

• 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: dorota wolpiuk ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 11101995
• MDR Text Key: 224794107
• Report Number: 2242352-2020-01149
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25153082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 63