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

Catalog Number C-HS-3045

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 02:41 pm (gmt-5:00) added by (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, the doctor tried many times to set the hs iii proximal seal according to the procedure; however, the seal was unable to be set.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5196188
• MDR Text Key: 30495947
• Report Number: 2242352-2015-01225
• 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: Physician
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2015
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25107210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2014
• 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