MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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, hs iii proximal seal system 3.8mm didn't deploy correctly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.Only the delivery device and the tension spring assembly and seal were returned to the factory.The loading device was not returned.The tension spring assembly remained inside the delivery tube with the seal hanging outside the tip of the tube.It was observed that the blue lock was disengaged and the white plunger un-pressed on the delivery device, which indicates no attempt to deploy the seal.The seal and tension spring assembly were pulled out from the delivery tube for inspection.Microscopic inspection showed the tether remained uncut and the seal appeared intact with no cracks nor delamination.No trace of blood on the seal indicates no attempt was made to deploy the seal into the aorta.Measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.198 in., the outer diameter was measured at 0.221in.The length of the delivery tube was measured at 2.51 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure activation problem was not confirmed.The analyzed failure fitting problem was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm didn't deploy correctly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8381977
• MDR Text Key: 137834632
• Report Number: 2242352-2019-00252
• Device Sequence Number: 1
• Product Code: DXC
• 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: 02/27/2019

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: 11/26/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25142966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1