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

Catalog Number C-HS-3045

Device Problem Malposition of Device (2616)

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

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 was misaligned from the proper position.A replacement device was used to complete the procedure.The hospital did not report any patient effects or information due to patient policy.

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance which could be considered related to the reported event recorded in the lot history.The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.The delivery device was returned outside the loading device.The seal and tension spring assembly remained inside the loading device.Traces of blood were observed on the loading device.The slide lock was di-engaged and the plunger was not depressed on the delivery device.The seal was taken out of the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.52 in.The values recorded were within the tolerance specifications.Based on the received condition of the device, the reported complaint for "failure to load" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal was misaligned from the proper position.A replacement device was used to complete the procedure.The hospital did not report any patient effects or information due to patient policy.

• Brand Name: HS III PROXIMAL SEAL
• 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: 6313134
• MDR Text Key: 67281168
• Report Number: 2242352-2017-00107
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2017
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25127486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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: 63 YR