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

Catalog Number C-HS-3045

Device Problem Device Slipped (1584)

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

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr¿s for the reported lot number. Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal dropped into the loader when the delivery system was pulled out. The hospital tried to insert it after rolling the seal up by hand, but couldn't. A replacement device was used to complete the procedure. The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint (b)(4). Autonumber # (b)(4).

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal dropped into the loader when the delivery system was pulled out. The hospital tried to insert it after rolling the seal up by hand, but couldn't. 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: 8095682
• Report Number: 2242352-2018-01194
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/25/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25138618
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No