MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR

Catalog Number C-HSK-3043

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 10/19/2018

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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not load properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not load properly.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.A visual inspection was performed.Signs of clinical use was observed.There was no evidence of blood detected.The delivery device was returned inside of the loading device, with the tension spring and seal still inside.The seal is visible through the window of the loading device.The delivery device was removed from the loading device.The plunger on the delivery device was not pressed and the blue sliding lock was observed to be in the locked position.The seal with the tension spring assembly were pulled out from the loading device for inspection.The tension spring assembly and tether wire was still connected to the seal.There were no cracks or delamination observed on the seal.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.198 in., the outer diameter was measured at 0.220 in.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure ¿fitting problem¿ is confirmed.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8207148
• MDR Text Key: 131906513
• Report Number: 2242352-2018-01385
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25135127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1