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

Catalog Number C-HSK-3038

Device Problems Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

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 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, hs iii proximal seal system 3.8mm seal would not deploy.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of blood and clinical use were observed.The delivery device was returned inside of the loading device, with the tension spring and seal remaining inside.The seal was visible at approximately the midpoint section inside the loading device, but remained outside of the delivery tube.Blood was observed on the external parts of the loading device.The white plunger on the delivery device remained unpressed and the blue lock remained in the locked position.There did not appear to be any attempt to deploy the seal.The seal was pulled out from the loading device for inspection.Microscopic inspection showed the tether remained uncut and attached to the seal and tension spring.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.2105 inches.The length of the delivery tube was measured at 2.497 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the results of the evaluation, 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 seal would not deploy.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 CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8580891
• MDR Text Key: 144258836
• Report Number: 2242352-2019-00515
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2020
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25144483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1