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

Catalog Number C-HSK-3038

Device Problem Difficult to Insert (1316)

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

Event Date 11/27/2017

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 a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was not able to be inserted within the deployment device completely and as it normally does and came out prior to being inserted into aorta.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use with no evidence of blood were observed.The delivery device was returned outside the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The tension spring assembly remained inside the delivery device with the seal and part of the tension spring extended hanging beyond the tip of the delivery tube.The tension spring assembly with the seal was removed from the delivery device for inspection.Microscopic inspection showed the seal to be intact, without cracks or delamination.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches., the outer diameter was measured at 0.214 inches.The length of the delivery tube was measured at 2.500 inches.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 "fitting problem" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was not able to be inserted within the deployment device completely and as it normally does and came out prior to being inserted into aorta.Device was not used on patient.No patient information available.The issue was noticed during loading.The seal was not able to be inserted.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
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7130880
• MDR Text Key: 95672237
• Report Number: 2242352-2017-01174
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: 09/20/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25134334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1