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

Model Number 10031#AVALON 31F

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "ecls coordinator said that interventional cardiologist has issues with this 31 fr avalon elite dual lumen catheter.He said that doctor had resistance at 8cm and was unable to advance the catheter.They tried multiple times under fluoroscopy and were not successful.He said the catheter kept wanting to kink or bend at 8cm.The doctor asked for a second 31 fr catheter.After inserting the catheter over the guidewire they had no issues with advancing the catheter.The doctor stated their is something wrong with this cannula since it wanted to kink or bend during insertion.No patient complications occurred" (b)(4).

Manufacturer Narrative

(b)(4).An avalon elite french catheter was delivered to the factory in a biokit.The catheter was curved on arrival, probably due to the way it was packed for returning to the factory.The catheter was examined and tested for kinks.When flexing the catheter with the inlet of the catheter pointing outwards, no sign of kinking was found.When flexing the catheter with the inlet of the catheter pointing inwards, a kink was found at the end of the wire reinforcement near the infusion outlet (right atrium).The issue was referred to r&d at maquet.The initial assessment was that the customer's reported issue is consistent with the catheter having been used without the introducer.The complaint/evaluation results were forwarded to avalon laboratories, the manufacturer.The product engineer manager at avalon evaluated the issue using retains from the same batch, and a scrap introducer, to try to replicate the failure.In his opinion, the most probable root cause is user error by not using the introducer during insertion or not having the introducer advanced far enough past the tip of the catheter.The ifu instructs the user to always use the introducer otherwise a kink may occur: "caution! never advance, position, or place the catheter without the introducer as this may kink and damage the catheter." the fact that no introducer was returned supports that an introducer was most likely not used.No further investigation or action is not possible and th complaint will be closed.This is the final report.

Event Description

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

• 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: 6486169
• MDR Text Key: 72794545
• Report Number: 8010762-2017-00120
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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 Model Number: 10031#AVALON 31F
• Device Catalogue Number: 701063538
• Device Lot Number: AM069281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 03/27/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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