MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS CANNULAE & PIK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PVL 2555 -J#BE-HLS CANNULA 25F VL

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that the guide wire did not pass through the introducer when attempting to introduce the hls cannula.The failure was detected during cannulation.However, customer changed the product during treatment without any harm to patient.The operation was completed successfully.At the end, it was found that the tip of the introducer was crushed.No harm to any person was reported.Complaint (b)(4).

• Brand Name: HLS CANNULAE & PIK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 19049350
• MDR Text Key: 339447882
• Report Number: 8010762-2024-00185
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2024

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 Model Number: BE-PVL 2555 -J#BE-HLS CANNULA 25F VL
• Device Catalogue Number: 701067505
• Device Lot Number: 3000309006
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/05/2024
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other