MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE; CLAMP, VASCULAR

Catalog Number C-HS-3045

Device Problems Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

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

Event Date 03/18/2019

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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

Hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn¿t deploy properly and it was unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).Corrected the date of return from (b)(6) 2019 to (b)(6) 2019.The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Blood was observed on the loading device.The delivery device was returned inside the loading device with the white plunger not depressed and the blue slide lock engaged.The seal was observed inside the loading device window.No visual defects were observed.The delivery device was removed from the loading device.The seal and tension spring remained inside the loading device.The seal and tension spring was removed from the loading device and inspected.No crack or delamination was observed on the seal.Measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.219in.The length of the delivery tube was measured at 2.52 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the return condition of the device, the reported failure "activation problem" was not confirmed.The analyzed failure "fitting problem" is confirmed.

Event Description

Hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn¿t deploy properly and it was unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8511867
• MDR Text Key: 141940211
• Report Number: 2242352-2019-00424
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25142214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1