MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR

Catalog Number C-HSK-3043

Device Problem Mechanical Problem (1384)

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

Event Date 02/21/2018

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 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 4.3 mm device did not load into delivery tube properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The hsk iii device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The delivery device was returned inside of the loading device.The seal was observed to be in the window of the loading device.The delivery device was removed from inside the loading device.There was no sign of blood in or on the delivery device and loading device.The slide lock was engaged and the plunger was not depressed on the delivery device.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly were removed from inside the loading device.There were no signs of crack/delamination of the seal and the tension spring assembly was completely in tact.No other failures were observed.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.198 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 "fitting problem; seal" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3 mm device did not load into delivery tube properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• 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: 7363822
• MDR Text Key: 103530328
• Report Number: 2242352-2018-00252
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25131190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Patient Age: 67 YR
• Patient Weight: 80