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

Model Number HST III SYSTEM (4.3MM)

Device Problems Fitting Problem (2183); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 preparation for a coronary artery bypass procedure hst iii system (4.3mm) didn't load properly into the deployment device.When removing the delivery device from the loading device the seal remained inside the loading device.Product never reached the patient on table, so no effect to patient.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h6- medical device problem code-corrected to "fitting problem." the device was returned to the factory for evaluation on 03/29/2021.An investigation was conducted on 04/05/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Only the delivery device with the seal and tension spring assembly was returned to the factory for evaluation.The seal and tension spring assembly was observed to be loaded into the delivery tube, with the seal and tension spring assembly.The seal was observed to be in opened state, with no visual defects observed.The white plunger on the delivery device was observed to be completely depressed with the blue slide lock disengaged.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties.There were no visual defects on the seal, no cracks or delamination was observed.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 (rm2036883).The length of the delivery tube was measured at 2.49 inches (mcv00004217).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 not confirmed.The lot # 25150767history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Ncmr #17077-sterile lot prep department notified qc that production order hsk-3038 - 25150768 was confirmed in work center: b300 and assigned to sterile load 0300009765.The material was then shipped to steris located in chester new jersey for sterilization.According to the certificate of processing from steris run id 227193a material hsk-3038 - 25150768 was sterilized.However, the actual batch that was shipped to the sterilizer was batch hsk-3043 - 25150767.Batch 25150767 has not been confirmed in sap and therefore does not appear as being sterilized on sterile load 0300009765.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure hst iii system (4.3mm) didn't load properly into the deployment device.When removing the delivery device from the loading device the seal remained inside the loading device.Product never reached the patient on table, so no effect to patient.A replacement device was used to complete the procedure.No patient involvement.

• Brand Name: HSK III SYSTEM (4.3MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 11602312
• MDR Text Key: 243744762
• Report Number: 2242352-2021-00248
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25150767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1