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

Catalog Number C-HSK-3038

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 06/24/2018

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 outer screen did not unfold during the procedure.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected from "(b)(6)" to "(b)(6)".Date of event from "(b)(6) 201" to "(b)(6) 2018".(b)(4).The hsk iii device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.The delivery device was returned outside of the loading device.The seal and tension spring assembly remained inside the loading device window.There was sign of blood on the back of the loading device.The slide lock was engaged and the plunger was fully depressed on the delivery device.The seal was removed from the loading device for inspection.There were no signs of cracks/delamination.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.197 inches, the outer diameter was measured at.221 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure mode ¿fitting problem¿ and analyzed failure mode ¿premature deployment" were confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal outer screen did not unfold during the procedure.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: 7696742
• MDR Text Key: 114674553
• Report Number: 2242352-2018-00683
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

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: 02/01/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25136926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Device Age: YR
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR