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

Catalog Number C-HSK-3038

Device Problem Difficult to Remove (1528)

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

Event Date 01/31/2018

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 a coronary artery bypass procedure, after loading the hs iii proximal seal system 3.8mm seal and when trying to pull out of the tube, it stayed inside the tube loader.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure, after loading the hs iii proximal seal system 3.8mm seal and when trying to pull out of the tube, it stayed inside the tube loader.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (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.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The tension and spring assembly remained inside the loading device when the delivery tube was removed.The tension spring assembly and the seal were removed from the loading device.A microscopic inspection was conducted.The seal was observed to have a crack on the outer coil.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 2.51 inches.The values recorded were within the tolerance specifications.Based on the return condition of the device and the results of the investigation, the reported complaint "fitting problem" was confirmed as well as the analyzed failure "cracked 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: 7291008
• MDR Text Key: 100920847
• Report Number: 2242352-2018-00172
• 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: 02/22/2018

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: 11/10/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25135481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Device Age: YR
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR