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

Catalog Number C-HSK-3038

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/14/2018

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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 38.Mm user noticed that there is space between seal line which could make blood leak through the crack.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Correction: "38.Mm" changed to "3.8mm".(b)(4).The device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.Small traces of blood were observed outside of the delivery tube and on the seal.No blood was observed inside of the delivery tube.The loading device was not returned with the delivery device.The tension spring assembly remained inside of the delivery tube.The seal was removed from the delivery tube and found to be cracked at the inner side of the coil.The blue slide lock was engaged and the white plunger was partially depressed on the delivery device.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured as.198 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "cracked seal" is confirmed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 3.8mm user noticed that there is space between seal line which could make blood leak through the crack.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: 7364075
• MDR Text Key: 103525315
• Report Number: 2242352-2018-00260
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: 11/13/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25135520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/30/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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: 70 YR
• Patient Weight: 65