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

Model Number PIK 150#INSERTION KIT, GUIDEWIRE 150 CM

Device Problem Fracture (1260)

Patient Problem Perforation of Vessels (2135)

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the guide wire was kinked when inserted into the body and it was broke when removed out from the body.Further, a resistance was observed during removing.Customer states that the broken guide wire caused to a blood vessel damage, and patient died during treatment.However, it is also stated that it is unknown if the exact reason of the death is caused by product or not.Customer states that complications from the cannulation procedure were the reason of the damage to patients health, and therefore there was no direct relationship between the broken guidewire and the patient's death.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: 19044359
• MDR Text Key: 339400431
• Report Number: 8010762-2024-00184
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131666
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIK 150#INSERTION KIT, GUIDEWIRE 150 CM
• Device Catalogue Number: 701047385
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/04/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death