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

Catalog Number C-HS-3045

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 02/27/2019

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 an endoscopic vein harvesting procedure using hs iii proximal seal was not loaded into the delivery device and unable to use.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 evaluation.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observe.Blood was observed on the loading device.The delivery device was returned inside the loading device with the white plunger on the delivery device not depressed, and the blue slide lock not engaged, with the seal observed in the loading device window.The delivery device was removed from the loading device, and the seal remained inside the loading device.The seal was removed from the loading device and inspected.The seal was observed to have a crack on the outermost ring of the seal.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.223 in.The length of the delivery tube was measured at 2.51 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure ¿fitting problem¿ is confirmed, and the analyzed failure "crack seal" was confirmed as well.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using hs iii proximal seal was not loaded into the delivery device and unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 8449419
• MDR Text Key: 139816428
• Report Number: 2242352-2019-00350
• 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: 03/01/2019

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: 04/25/2019
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25138618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1