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

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The catheter was not returned, as it was reported to have been left within the patient.Attempts have been made to obtain additional information.However, our attempts have been unsuccessful.Based on the reported information, the report of entrapment could not be confirmed and the cause could not be determined.There is no evidence suggesting that the catheter was defective, but rather a procedure related event.Angioarchitecture, vasospasm, reflux, long catheter dwell time, or prolonged injection time may result in difficult catheter removal and potential entrapment.For this event, it is possible the reported excessive reflux or prolonged injection time contributed to the reported issue.All products are 100% inspected for damages and irregularities during manufacture.Per the reported information, the catheter that was used was either a marathon or echelon-10.We were unable to verify the which device was used.Per the liquid embolic material instructions for use (ifu): do not allow more than 1 cm of liquid embolic material to reflux back over catheter tip.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.Linked events: 2029214-2017-00813 2029214-2017-00814.

Event Description

Citation: ¿results and complications of transarterial embolization of intracranial dural arteriovenous fistulas using onyx-18¿ xianli lv, m.D., chuhan jiang, m.D., youxiang li, m.D., j.Neurosurg./ volume 109 / december 2008 medtronic received report that 31 patients with intracranial dural arteriovenous fistulas davfs were treated with onyx 18.There were 10 women and 21 men, ranging in age from 23 to 60 years (mean 43 years).There was one case that was reported to have gluing of the microcatheter.This patient was a (b)(6) male that presented with intracerebral hemorrhage (ich).The davf was successfully treated and the patient was asymptomatic post intervention.The gluing of the microcatheter in 1 patient resulted from a long reflux and long injection time (25 minutes).The catheter was not removed from the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6655684
• MDR Text Key: 78188078
• Report Number: 2029214-2017-00815
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 05/24/2017

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: 05/24/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 05/24/2017
• Supplement Dates FDA Received: 10/04/2017
• 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
• Patient Age: 23 YR