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

Catalog Number C-HSK-3038

Device Problem Misfire (2532)

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

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 misfired.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.Signs of clinical usage and slight evidence of blood were observed.The delivery device was returned outside of the loading device.Specks of blood were observed on the loading device and on the delivery device plunger.The anchor and tension spring assembly were observed not to be fully loaded into the delivery tube.The seal was observed to be extended outside the delivery tube.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The tension spring assembly and the seal were then pulled out from the delivery tube for inspection.Microscopic inspection showed the seal intact, without cracks nor delamination.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.196 in.The outer diameter was measured at 0.221 in.The length of the delivery tube was measured at 2.52 in.The measurement values recorded for the delivery tube were within the tolerance specifications.Based upon the received condition of the device, and the results of the evaluation, the reported failure mode "activation problem; seal" was not confirmed, but was confirmed for the analyzed failure mode "fitting problem".A lot history record review was completed for lots 25135995, 25136794, and 25137394 the last 3 lots shipped to the account prior to the event date.There were no ncmr¿s recorded in the lot history.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm misfired.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: 7858713
• MDR Text Key: 119809973
• Report Number: 2242352-2018-00877
• 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: 09/07/2018

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 Catalogue Number: C-HSK-3038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/09/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1