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

Catalog Number C-HS-3045

Device Problem Positioning Failure (1158)

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

Event Date 05/18/2018

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 did not deploy properly in the patient's aorta and came out when the customer pulled out the delivery device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: event site city and event site postal code; lot # and expiration date; manufacture date.(b)(6).Corrected lot # from "25135578" to "25136334".Corrected expiration date from "11/16/2018" to "01/08/2019".Corrected mfr date from "11/16/2017" to "01/08/2018".(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system did not deploy properly in the patient's aorta and came out when the customer pulled out the delivery device.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 D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7603497
• MDR Text Key: 111845706
• Report Number: 2242352-2018-00550
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25136334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1