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

Model Number 10027#AVALON ELITE

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Importer- (b)(4).Contact person- (b)(6).The device was requested but not yet received.

Event Description

According to the customer: dr.(b)(6) placed the guide wire and the avalon elite catheter ( 27fr ) but was unable to with-drawl the guide wire after placement.Several attempts were made without success.So both the guide wire and catheter were removed.They completed the procedure with a new guide wire and new catheter with no further complications.Additional information: ¿a (b)(6) male patient was requiring pulmonary support.Dr.(b)(6) dilated the right ij using the avalon insertion kit.The guide wire was in place, the 27f avalon was inserted appropriately and in correct position.Dr.(b)(6) attempted to pull out the guide wire.However, the guide wire got stuck in the avalon cannula requiring him to pull out the avalon and use another 27f.¿ no harm to the patient was reported.Internal reference: (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

Maquet medical systems,usa (importer) submits this report on behalf of the legal manufacturer of the device (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).(b)(6).The product was requested for return to the manufacturer for laboratory investigation.The product was returned but was not investigated in the complaints lab because the device may contain biological residue of who risk group 3 considered to be infectious such as (b)(6).Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated already was performed and no similar complaints were found.Thus the reported failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: CATHETER, CARDIOPULMONARY BYPASS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7889254
• MDR Text Key: 120975307
• Report Number: 8010762-2018-00261
• 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
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10027#AVALON ELITE
• Device Catalogue Number: 701063537
• Device Lot Number: 203389
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR