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

Model Number PIK 100#INSERTION KIT, GUIDEWIRE 100 CM

Device Problem Break (1069)

Patient Problem Foreign Body Reaction (1868)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the user felt the insertion kit (pik 100) get stuck during withdrawal however customer proceed the treatment without any harm.After 4 days, customer found an impurity on body and when customer retrieved the impurity back, it was found that it could be related with the tip of the severed guide wire which was used 4 days ago.Potential for harm is 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: 19046025
• MDR Text Key: 339436195
• Report Number: 3008355164-2024-00009
• 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: Distributor
• 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

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIK 100#INSERTION KIT, GUIDEWIRE 100 CM
• Device Catalogue Number: 701047384
• Device Lot Number: 3000350474
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2024
• Distributor Facility Aware Date: 04/01/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2024
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 10/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other