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

Catalog Number C-HS-3045

Device Problems Crack (1135); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

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 using hs iii proximal seal, they noticed that the proximal seal was deformed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).Corrected section: corrected event description from "the hospital did not report any patient effects." to "there was no patient involvement." the device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device.The white plunger was not depressed and the slide lock was not engaged.The seal and tension spring was observed in the loading device window.The delivery device was removed from the loading device.The seal and tension spring remained inside the loading device.The seal and tension spring assembly was removed from the loading device.No cracks or delamination was observed on the seal.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "crack seal" is not confirmed, but was confirmed for the analyzed failure "fitting problem".

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using hs iii proximal seal, they noticed that the proximal seal was deformed.A replacement device was used to complete the procedure.There was no patient involvement.

• Brand Name: HS III PROXIMAL SEAL
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8559839
• MDR Text Key: 143551344
• Report Number: 2242352-2019-00487
• 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: 04/26/2019

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: 09/25/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25141792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1