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

Catalog Number C-HS-3045

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/18/2018

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 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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn't deploy properly and was unable to be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use was observed.There was no evidence of blood detected.The delivery device was returned within the loading device, with the seal and tension spring assembly visible within the window of the loading device.The blue slide lock was disengaged and the plunger fully pressed.The delivery device was pulled out from the loading device.The tension spring assembly and the seal remained inside the delivery tube.The tension spring assembly and the seal were then pulled out from the delivery tube for inspection.Further analysis revealed that the seal is unraveled at the outer edges.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 0.217 in.The length of the delivery tube was measured at 2.46 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 "activation problem" is confirmed, and the analyzed failure "unraveled seal" is confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn't deploy properly and was unable to 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
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8237813
• MDR Text Key: 132782114
• Report Number: 2242352-2019-00049
• 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: 01/10/2019

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: 07/10/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25140159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1