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 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25152041 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the 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 07oct2020 and investigated on 09oct2020.Photographs from the account shows that the white plunger on the delivery device remained unpressed, the tension spring assembly remained inside the delivery tube with the seal in an open state outside of the delivery device.Signs of clinical use and evidence of blood was observed on the package, cutter and loading device.The seal can be observed in an open state at the delivery window of the loading device.The safety lock on the cutter was engaged and the actuation button was not fully depressed.The condition of the spiral needle cannot be seen due to the lid on the tip of the cutter.A visual inspection was conducted.Signs of clinical usage and evidence of blood was observed.Specks of blood was observed on the loading device.The cutter was not returned for evaluation.The delivery device and seal- tension spring assembly were returned inside the loading device.The white plunger on the delivery device remained unpressed and the blue lock remained in the locked position.The tension spring assembly remained inside the delivery tube with the seal in an open state outside of the delivery device after being removed from the loading device.No other failures were observed.The seal and tension spring assembly remained inside the loading device after delivery device was removed.The seal was taken out from the loading device for inspection.The tether remained uncut and attached to the seal and tension spring.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at 0.198 inches; the outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "fitting problem" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal loading did not work 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 10702163
• MDR Text Key: 212720359
• Report Number: 2242352-2020-00896
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25152041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• 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