MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (4.3MM)

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

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 (4.3mm) failed to deploy during a case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25153151 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.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.A visible crack was observed on the middle and outer end of the seal.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 dimensions of the delivery tube were taken.The inner diameter was measured at 0.197 in., the outer diameter was measured at 0.220 in.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 received condition of the device the reported ¿activation problem¿ was not confirmed but confirmed for analyzed failure modes ¿fitting problem¿, and "crack; seal".

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) failed to deploy during a case.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HSK III SYSTEM (4.3MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10711600
• MDR Text Key: 212311988
• Report Number: 2242352-2020-00905
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• 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: 10/19/2020

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: 08/21/2021
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25153151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR