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

Model Number PIK 100

Device Problems Partial Blockage (1065); Failure to Advance (2524)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "after failing with the first percutaneous introducer kit, another one was used.But when inserting the guide wire through the needle, the guide wire remained blocked and no longer slided, making the procedure impossible to continue.The needle and the guide wire had to be removed jointly.Lengthening of the procedure and management of a critical patient.Another kit had to be opened and used." (b)(4).

Manufacturer Narrative

(b)(4).The sample was examined visually by laboratory.The guidewire showed severe damage, strong kinks and deformations were observed.Before cleaning and after cleaning with sodium hypochloride,the still intact other end of the guidewire was pushed through the needle, which has been successfully done both times.The guide wire can be pushed through the needle without problems at the intact end.It could be possible that the guide wire could be damaged if the customer pulled out of the needle strongly.The complaint could not be confirmed by the laboratory.The available information has been shared internally with the clinical consultant.The wire was extended along its length and kinked at multiple.This usually happens if the wire is blocked by an angulation.The tip of the wire then pushes to the endothelial wall of the vessel and interlocks.Removing gets difficult and enhanced tensile force is necessary to retract the catheter from the vessel.Due to the enhanced tensile force, the wire gets spoiled and pulled apart along the metal elements when reversely passing the needle.Wire deformation is mostly pronounced at the tip due to the consistence of the relatively soft material.Taken together,a typical complication of central venous or arterial cannulation has been reported in the complaint.Together with the material investigation, we cannot confirm a product related malfunction.A review of the device history record was performed with no abnormality found.A trend search has been performed, 1 additional complaint was found.The probable root cause could be determined as a user failure.Neither a product malfunction nor a systemic issue is indicated, therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.

Event Description

Ref # (b)(4), customer ref # (b)(4).

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6368185
• MDR Text Key: 69095888
• Report Number: 8010762-2017-00065
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

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: 11/01/2018
• Device Model Number: PIK 100
• Device Catalogue Number: 701047384
• Device Lot Number: 92182007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: 02/03/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1