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

Catalog Number C-HSK-3038

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 preparation for a coronary artery bypass procedure, hs iii proximal seal 3.8mm upon squeezing wings, heartstring did not properly roll.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal 3.8mm upon squeezing wings, heartstring did not properly roll.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 and no evidence of blood were observed.The delivery device was returned inside the loading device with the seal and tension spring assembly observed in the loading device.The blue slide lock was disengaged and the white plunger was fully depressed on the delivery device.The delivery device was removed from the loading device and the seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device.The seal was observed to be slightly cracked on the outermost coil of the seal.No other visual defects were observed.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.198 in., the outer diameter was measured at 0.218 in.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the return condition of the device, the reported failure "fitting problem" was confirmed as well as confirmed for the analyzed failures "premature deployment" as well as "crack seal".

• 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: 7642064
• MDR Text Key: 112713942
• Report Number: 2242352-2018-00599
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K080169
• 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: 06/26/2018

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: 01/25/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25136763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 08/14/2018
• Supplement Dates FDA Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1