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

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The catheter was not returned for analysis.Attempts have been made to obtain additional information, however our attempts have been unsuccessful.A marathon or an ultraflow catheter was used in this case, however, it unknown which of these two catheters encountered this event.The report of catheter entrapment/difficult removal could not be confirmed, and the event cause could not be determined.It is possible that excessive liquid embolic reflux may have contributed to the reported issue.Per our instructions for use (ifu): do not allow more than 1 cm of the liquid embolic to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive liquid embolic reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment.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 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.All products are 100% inspected for damages and irregularities during manufacture.Linked event: 2029214-2017-00819, 2029214-2017-00820, 2029214-2017-00821.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: embolization of intracranial arteriovenous malformations with ethylene-vinyl alcohol copolymer (onyx)¿ v.Panagiotopoulos, e.Gizewski, s.Asgari.Ajnr am j neuroradiol.2009 jan;30(1):99-106.Doi: 10.3174/ajnr.A1314.Epub 2008 oct 8.Medtronic received the following reports: there was one case where a microballoon was used for preventing coil migration into the venous side of a fistulous part of an avm, the device stuck and could not be removed.The patient was symptomatic post intervention.There was another trapped microcatheter in the posterior circulation, which did not add clinical morbidity to our cohort.

• 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: 6656736
• MDR Text Key: 78157103
• Report Number: 2029214-2017-00820
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/21/2017
• 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