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

Catalog Number C-HSK-3043

Device Problems Difficult to Remove (1528); Fitting Problem (2183)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2018

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 using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be pulled out normally.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 using hs iii proximal seal system 4.3mm.They found that the protective umbrella of the proximal heartstring could not be pulled out normally.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).Only the seal and tension spring assembly was returned to the factory for evaluation.A visual inspection was conducted.Only the seal and tension spring was returned for evaluation.Signs of clinical use and no evidence of blood was observed.The seal and tension spring was observed to be intact, no visual defects were observed.The seal was observed to be intact, no visual defects were observed.Based on the incomplete device return, the reported failure "fitting problem" was not confirmed.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8420977
• MDR Text Key: 138953580
• Report Number: 2242352-2019-00300
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25138591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Device Age: YR
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 75