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 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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 3 minutes.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is 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 3 minutes.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is 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 3 minutes.Investigation is required.The defective product will be returned.Credit note has been requested.Investigation is required.The defective product will be returned.Credit note has been requested.

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 was returned to maquet for evaluation.The delivery device was returned inside the loading device.The seal and tension spring assembly were present in the loading device.There was no blood observed inside the delivery tube/ device.The slide lock was engaged, the plunger was not depressed.The following measurements were taken; the inner delivery tube diameter was measured as.197 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.5 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for failure to load was confirmed.Specific actions for this failure mode are being managed and documented in the maquet corrective and preventive action (capa) system.

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 3 minutes.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is 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 3 minutes.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is 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 3 minutes.Investigation is required.The defective product will be returned.Credit note has been requested.Investigation is required.The defective product will be returned.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: 5535186
• MDR Text Key: 41779624
• Report Number: 2242352-2016-00300
• 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

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2016
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25120570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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