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

Catalog Number C-HSK-3038

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 11/27/2018

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 a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was inserted normally into the aorta.However, the seal loosened and a leak occurred.The patient did not experience any significant blood loss.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # tw (b)(4).Autonumber: (b)(4).A photographic inspection was performed.Based on he photo received from the client, the components involved are the loading device, delivery device and aortic cutter and seal.They all appeared bloody.The aortic cutter needle is visible, indicating use.The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood were observed on the loading device, delivery device and seal.The aortic cutter and the tether were not returned to the factory.The delivery device was inside the loading device when it was returned.The seal was unraveled and was outside the delivery device.The blue lock was disengaged and the white plunger on the delivery device was fully pressed.The delivery device was pulled out from the loading device for inspection.It was observed that blood was all over the delivery device both inside and outside, indicating deployment of the seal into the aorta.Dimensional measurements of the delivery device cannot be taken due to its contaminated state.Microscopic inspection showed the seal unraveled and tainted with blood.Based on the returned condition of the device and evaluation results, the reported failure leak was not confirmed.The presence of blood inside the delivery device and the unraveled seal indicates proper deployment.There is no indication of non-conformance on the reported device.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal was inserted normally into the aorta.However, the seal loosened and a leak occurred.The patient did not experience any significant blood loss.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 CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8299138
• MDR Text Key: 134984573
• Report Number: 2242352-2019-00138
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25135907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Device Age: YR
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 75