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

Model Number HST III SYSTEM (3.8MM)

Device Problems Failure to Unfold or Unwrap (1669); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2020

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 (3.8mm) seal was properly installed in the tube at the delivery device, during the separation, the seal is caught in the middle of the delivery device and does not come off.The seal was forcibly removed and installed, but the seal fail to unwrap and could not be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly installed in the tube at the delivery device, during the separation, the seal is caught in the middle of the delivery device and does not come off.The seal was forcibly removed and installed, but the seal fail to unwarp and could not be used.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 # 25150894 history record review was completed.There was an ncmr # 17080 initiated since supplier caused the nonconformance and this ncmr is not related to reported failure.There were no 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 27oct2020.Photograph of the loading device, shows that the tension spring and seal remained inside the loading device.The seal did not appear to be folded.The returned device was investigated on 28dec2020.Signs of clinical use and no evidence of blood were observed.Delivery device was returned inside loading device.The delivery device was removed from the loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was then pulled out from the loading device for inspection.The seal did not appear to be folded.There was no sign of crack/delamination on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.220 inches.The length of the delivery tube was measured at 2.500 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and evaluation results, the reported failures "failure to unfold or unwrap" and "activation problem" were not confirmed but the analyzed failures "fitting problem" and "premature deployment" were confirmed.

• Brand Name: HSK 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: 10825237
• MDR Text Key: 217982933
• Report Number: 2242352-2020-00989
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25150894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 77