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

Model Number HST III SYSTEM (4.3MM)

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) did not properly load into the deployment device and got stuck in the rolling and loading device.The device never left the back table and was never in contact with the patient at any time.Another device was used to complete the case.

Manufacturer Narrative

Internal complaint number: (b)(4).The lot # 25154949 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) 2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger fully depressed and the blue slide lock dis-engaged and not in its normal position.The seal and tension spring assembly was observed inside the loading device window.The delivery device was removed from the loading device.The seal and tension spring assembly remained inside the loading device.There were no visual defects observed on the seal or tension spring assembly.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.219 inches (b)(6).The length of the delivery tube was measured at 2.49 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed as well as for the analyzed failure "premature deployment".

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) did not properly load into the deployment device and got stuck in the rolling and loading device.The device never left the back table and was never in contact with the patient at any time.Another device was used to complete the case.

• 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: 11375993
• MDR Text Key: 233443635
• Report Number: 2242352-2021-00166
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25154949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1