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

Model Number 10027#AVALON

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer of the product performed a dhr review with the following results: sterilization load work order # (b)(4) and individual work order (b)(4) where lot am063559 was processed were reviewed.According to the records there were no deviations or non-conformances associated with this sterilization load.The sterilization load was released by maquet on april 27, 2016.The dhr for (b)(4) (p/n 10027ns - packaging) non- sterile configuration was reviewed.According to the records there was one deviation to inspect labeled product 100% post pouch sealing.There weren't any non-conformances associated with this lot or notes indicating cannula/introducer difficulty during the 100% fit check that is part of the assembly process.According to the record the product was correctly built and released on april 19, 2016.The incoming inspection record for the introducer used (p/n 25980, lot # 25980-ca-0019 was reviewed.There were no deviations or non-conformance reports associated with the purchased material.Based on the sample size inspected during receiving inspection the lot met the outside diameter speciation of 0.217¿ ±0.004¿.Maquet cardiopulmonary requested the product back for investigation, but it was not yet received.The investigation of mcp is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: "the physician was not able to place the introducer packaged with the 27french avalon into the cannula.They stated the introducer was too large to fit inside the 27 french cannula and needed to open a 23 french cannula and utilize that introducer." (b)(4).

Manufacturer Narrative

(b)(4).The introducer of an avalon catheter was delivered to the factory in a biotainer.The catheter itself and the guidewire used to guide the introducer into the catheter were not returned.The introducer was investigated in the decontamination / complaints laboratory.Note that for a meaningful investigation to be carried out, the customer should have returned the original catheter, so that it could have been established if/why the returned introducer did not fit in the catheter as alleged.As such, it was not possible to check whether the introducer fits in the avalon catheter or not.There were no signs of any defects or damage on the introducer itself.In order to establish the correct identity of the introducer returned to the factory, it was measured and compared to the engineering drawing for the introducer for the avalon french 27 catheter (drawing numbers (b)(4) ((b)(4)), and it was confirmed that the introducer is a 27fr bicaval introducer, 0.217".No deviations from the specifications were found.In the absence of the affected catheter, a proper investigation could not be performed and the customer's reported issue could not be confirmed, and a root cause could not be established.It is therefore also not possible to counter the customer's allegation, so the allegation stands.Based on the investigation and trending for this issue, a systemic issue is not indicated, and no further investigation or action is currently warranted or possible, therefore the complaint will be closed.

Event Description

(b)(4).

• Brand Name: CATHETER, CANNULA
• 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: 6435887
• MDR Text Key: 71216389
• Report Number: 8010762-2017-00102
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10027#AVALON
• Device Catalogue Number: 70105.5982
• Device Lot Number: AM063559
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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