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

Catalog Number C-HS-3045

Device Problem Component Falling (1105)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4): 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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

(b)(4): the hospital reported that during a coronary artery bypass procedure, hs iii proximal seal dropped inside of the delivery device and caused the surgery to be prolonged by 1 minute.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.(b)(4): the hospital reported that during an endoscopic vein harvesting procedure, hs iii proximal seal dropped inside of the delivery device and caused the surgery to be prolonged by 1 minute.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.(b)(4): during preparation, the seal dropped inside of the delivery device.Another product was used to complete the procedure.No patient injury was reported.The surgery prolonged by 1 minute.Investigation is not required.The defective product will not be returned since it was discarded in the hospital.Credit note has been requested.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal dropped inside of the delivery device and caused the surgery to be prolonged by 1 minute.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.The hospital reported that during an endoscopic vein harvesting procedure, hs iii proximal seal dropped inside of the delivery device and caused the surgery to be prolonged by 1 minute.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is not returning.During preparation, the seal dropped inside of the delivery device.Another product was used to complete the procedure.No patient injury was reported.The surgery prolonged by 1 minute.Investigation is not required.The defective product will not be returned since it was discarded in the hospital.Credit note has been requested.

• 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: 5535180
• MDR Text Key: 41777002
• Report Number: 2242352-2016-00301
• 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: 03/03/2016

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: 03/19/2016
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25112423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Date Device Manufactured: 03/20/2015
• 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