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

Model Number HST III SYSTEM (3.8MM)

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

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 an endoscopic vein harvesting procedure, hst iii system (3.8mm) had already deployed when package was opened.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4, g7, h2, h3, h6, h10.Trackwise # (b)(4).The device was returned to the factory for evaluation on 12/27/2019.An investigation was conducted on 02/04/2020.A visual inspection was conducted.While it was reported that the failure occurred prior to the package being opened, signs of clinical use and slight evidence of blood was observed on the side of the loading device.The delivery device was returned partially inside the loading device with the white plunger not depressed and the blue slide lock not engaged.The delivery device was removed from the loading device.The seal and tension spring assembly remained inside the loading device.Based on the position of the seal and the white plunger, we can conclude that the seal was not loaded correctly.The seal and tension spring assembly was removed from the loading device.No visual defects were observed.The following measurements were taken; the inner delivery tube diameter was measured at.196 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint ¿premature deployment¿ was not confirmed but was confirmed for the analyzed failure ¿fitting problem¿.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hst iii system (3.8mm) had already deployed when package was opened.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: 9566450
• MDR Text Key: 188404567
• Report Number: 2242352-2020-00036
• Device Sequence Number: 1
• Product Code: DXC
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2020
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25148201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 90