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

Catalog Number C-HSK-3038

Device Problems Loose or Intermittent Connection (1371); Unraveled Material (1664)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

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 a coronary artery bypass procedure using hs iii proximal seal system 3.8mm.The user installed the seal on the delivery device but the central portion of the proximal seal was loose and could not be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected sections: a-3 - sex; b-5 - describe event or problem.Corrected a-3 from "female" to "male.Corrected b-5 to reflect the corrected updated information.(b)(4).A photographic evaluation showed the seal partially inside the delivery tube in a folded taco position and cracked in the middle coil of the seal.The loading device, delivery device and aortic cutter were in the original package with no sign of blood.The plunger on the delivery device was not depressed, we were unable to determine the position of the blue slide lock.The safety lock was disengaged and the actuation button fully depressed inside the aortic cutter tool.We were unable to determine the state of the spiral needle.The hsk iii device was returned to factory for evaluation.Signs clinical use and no evidence of blood were observed.A visual inspection was conducted.The delivery device was returned outside of the loading device.The tension spring was returned inside the delivery tube with the seal slightly loaded into the tube.The seal was observed to be in a folded taco position and cracked in the middle coil of the seal.The seal and tension spring assembly were removed from inside the delivery tube.The tension spring assembly was completely intact.The blue slide lock was dis-engaged and the plunger was slightly depressed.No other visual defects were observed.The following measurements were taken; the inner delivery tube diameter was measured at.196 in.The outer diameter was measured at.220 in.(rm2036883).The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based on the returned condition of the device and the evaluation reported, failure mode ¿unraveled material¿ was unable to be confirmed but confirmed for analyzed failure ¿crack; seal¿.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using hs iii proximal seal system 3.8mm.The user installed the seal on the delivery device but the central portion of the proximal seal was loose and could not be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8535338
• MDR Text Key: 142881068
• Report Number: 2242352-2019-00471
• 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: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25139407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Device Age: YR
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 71