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

Catalog Number C-HSK-3038

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

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 preparation for an endoscopic vein harvesting procedure, hs iiii proximal seal system 3.8mm failed to load and deploy properly.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hs iiii proximal seal system 3.8mm failed to load.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

(b)(4).Only the loading device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.There were no visual defects observed on the loading device.An evaluation of the seal cannot be performed as it was not returned with the device.We are unable to evaluate the delivery device as it was not returned.We were unable to confirm the reported failure since the delivery device as well as the tension spring assembly and seal were not returned for evaluation.

• 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: 7611905
• MDR Text Key: 111858808
• Report Number: 2242352-2018-00563
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25137258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1