MAUDE Adverse Event Report: COVIDIEN (IRVINE) NV MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage, Subarachnoid (1893); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The microcatheter was not returned for analysis.Attempts have been made to obtain additional information.However, our attempts have been unsuccessful.As the device was not returned, we are unable to perform further root cause analysis.Per the reported information, it appears as if the user's technic caused the reported events.Hemorrhages are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Per our instructions for use (ifu): difficult catheter removal or catheter entrapment may be caused by one or more of the following factors: long catheterization time; angio-architecture (very distal arteriovenous malformation fed by afferent, lengthened, small, or tortuous pedicles); vasospasm; reflux; injection time.To reduce the risk of catheter entrapment, carefully select catheter placement and manage reflux to minimize the factors listed above.Liquid embolic material reflux along the distal tip of the micro catheter: apart from the risk of ischemic complications due to unintended embolization, significant reflux may result in entrapment of the micro catheter causing difficult removal.The amount of reflux that can be accepted must always be compared to the angio-architecture of the malformation to minimize risk of unintended embolization or difficult catheter removal.In general, minimize the reflux to less than 1 cm along the distal tip of the micro catheter.All other factors may affect this limit.Linked events: 2029214-2017-00956 2029214-2017-00957 2029214-2017-00958.

Event Description

Citation: ¿transvenous embolization in pediatric plexiform arteriovenous malformations¿ george a.C.Mendes, md.Christina iosif, md, phd.Eduardo pedrolo silveira, md.Eduardo waihrich, md.Suzana saleme, md.Charbel mounayer, md, phd.Medtronic received report the following reports: the mean age was 13.5 years (range, 11-16 years), and 4 females and 3 males.All patients presented with hemorrhage, and 71% of avms were located deeply.A successful intranidal position of the venous microcatheter was achieved in all procedures, and anatomic exclusion of the nidus was documented in 7 patients.There were no vessel perforations or ischemic events.No neurological deficit or complications post intervention.There was a single complication reported, the patient experience a subarachnoid hemorrhage related to a retained arterial microcatheter without clinical consequences to the patient.The microcatheters were intentionally left in place at the level of the jugular sheath.

• Brand Name: NV MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6785797
• MDR Text Key: 82467709
• Report Number: 2029214-2017-00958
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Disability