MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG AVALON 13 FRENCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 701063529

Device Problem Difficult to Remove (1528)

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

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: it was reported that after insertion of the 13 french avalon cannula into the right ij the obterator could not be removed.The cannula was then removed and ecls support was initiated through central cannulation.Additional information: there were no negative consequences for the patient reported.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person- (b)(6).The defective part has arrived for investigation: an avalon elite 13 fr has been returned.The sample was contaminated.Sample was cleaned with sodium hypochlorite.Visual inspection performed.No abnormalities could be detected.The introducer could be pulled out of the catheter normally and pushed back in again.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

Ref.: (b)(4).Customer ref.: (b)(4).

• Brand Name: AVALON 13 FRENCH CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7973984
• MDR Text Key: 124124267
• Report Number: 8010762-2018-00281
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701063529
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention