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

Catalog Number C-HSK-3043

Device Problem Positioning Problem (3009)

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

Event Date 07/05/2018

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

Manufacturer Narrative

(b)(4).The device was returned to the factory for investigation.Signs of clinical use and no evidence of blood were detected.Only the seal and tension spring assembly were returned.There were cracks observed on the outer coil and middle coil of the seal.There were no defects detected in regard the tension spring.Based on what was returned, and the condition of the components, the reported failure "fitting problem" is not confirmed, however the analyzed failure "cracked seal" 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: 7740793
• MDR Text Key: 115908093
• Report Number: 2242352-2018-00728
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K080169
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2019
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25137371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Device Age: YR
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 83