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

Model Number PIK 150#INSERTION KIT, GUIDEWIRE 150 CM

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that containment support of the guide is not suitable for insertion in the introducer.Further, it was also reported that non-supportive guide with frequent folding and frequent incarceration of the same in the lumen of the vessel cause to removing problems.No harm to any person was reported.Complaint #(b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

It was reported that containment support of the guide is not suitable for insertion in the introducer.Further, it was also reported that non-supportive guide with frequent folding and frequent incarceration of the same in the lumen of the vessel cause to removing problems.No harm to any person was reported.The following information has been received from customer on 2023-08-07: ¿the problem has occurred at multiple times, inserting the guide into the needle was difficult.In particular it is practically not possible to insert through the facilitator that is firmly connected to the container of the guide.The result is that the guide can be approached by the introducer needle only still contained in the guide winding system in its entirety.The difficulties of carrying out the introduction manoeuvre are therefore obvious for the weight of the guidewire system and cause the facilitator that are integral to each other.Secondly, it is essentially impossible to remove the guide at the end of the procedure because the guide was folded in on itself.¿ - it is possible that excessive tensions and pressures occur on the product during use.- customer felt resistance during insertion.- no damage was observed during the visual control.More information has been requested from customer on 2023-08-14.Ssu sent the first mail on 2023-08-21 then two reminders sent on 2023-09-11 and 2023-09-25.No answer has been received from customer.Laboratory investigation could not be performed since the sample could not be provided by customer.Further, the incoming inspection reports of the affected components fem guidewire advancer (batch # 3000242783) and guidewire (batch # 3000180100) were reviewed on 2023-10-05.The fem guidewire advancer was checked dimensionally for if the gate stub is no larger than 0.020.Also, visual control was performed for if surface of material is free of excessive sinks.The guidewire was checked for the guidewire regarding shapelessness/crimp in the area of tip.There shall not be any openness between wires.Also, the outer dimension was controlled according to the specified limits.All tests were passed as per specifications.The review of the non-conformities has been performed.It does not show any non-conformity in regards to the reported product and failure.The production history record (dhr) of the affected pik 150# insertion kit, guidewire 150 cm with lot# 3000301195 was reviewed on 2023-08-23.According to the dhr result, the product pik 150#insertion kit, guidewire 150 cm passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the investigation results, the failure could be confirmed.The exact root cause could not be determined, however the reported failure could be linked to the risk assessment file of pik sets and the probable cause could be: - user failure: applied external forces on the product during insertion could cause kinked and therefore it will cause a problem during removal.- manufacturing: material failure could be the reason of the kink problem.These root causes could not be confirmed due to the lack of information and sample.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : 4115.

• Brand Name: CANNULA & CATHETER
• 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: 17469553
• MDR Text Key: 320490626
• Report Number: 8010762-2023-00378
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/26/2023

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: PIK 150#INSERTION KIT, GUIDEWIRE 150 CM
• Device Catalogue Number: 701047385
• Device Lot Number: 3000301195
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other