MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

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.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 an endoscopic vein harvesting procedure, hs iiii proximal seal system 3.8mm failed to load and deploy properly.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hs iiii proximal seal system 3.8mm failed to load and deploy properly.No patient involvement.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.The delivery device was returned inside the loading device.The blue slide lock was engaged and the white plunger was not depressed on the delivery device.The seal was observed in the loading device window, the seals outermost coil was observed to be cracked.The delivery device was removed from the loading device with the seal and assembly remaining in the loading device.The seal and tension spring assembly were pulled from the loading device.The seal was observed to have a slight crack in the outmost coil of the seal.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.225 in.The length of the delivery tube was measured at 2.51 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based upon the received condition of the device, and the results of the evaluation, the reported failure mode "fitting problem" and the analyzed failure "cracked seal" were confirmed.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7611570
• MDR Text Key: 111897728
• Report Number: 2242352-2018-00562
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: 02/15/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25137258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1