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

Catalog Number C-HSK-3043

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/15/2018

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 4.3mm umbrella was not mounted in the conveying device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Initial reporter - event site state - (b)(6).Internal complaint number: (b)(4).Autonumber: (b)(4).Only the seal and tension spring assembly were returned to the factory for evaluation.The loading device and the delivery device were not returned.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.The tether remained uncut.The seal has a crack on the edge.Based on the returned condition of the device and the evaluation results, the reported failure "fitting problem" was not confirmed.The analyzed failure "crack" was confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm umbrella was not mounted in the conveying device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 8143898
• MDR Text Key: 129887193
• Report Number: 2242352-2018-01268
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2019
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25140467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Device Age: YR
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65