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

Catalog Number C-HSK-3038

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 11/19/2018

Event Type  Injury  

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 system 3.8mm did not completely roll in the delivery device loading tube.The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube.The doctor then used a side-biting clamp on the aorta.The hospital did not report any patient effects.

Event Description

The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm did not completely roll in the delivery device loading tube.The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube.The doctor then used a side-biting clamp on the aorta.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 not connected to the seal.The tether remained uncut.The seal was observed to be unraveled at the center.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¿ was confirmed, and the analyzed failure "unraveled seal" is confirmed.

• 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: 8187595
• MDR Text Key: 131130584
• Report Number: 2242352-2018-01341
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25136433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Device Age: YR
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 57