MAUDE Adverse Event Report: COVIDIEN MICROSNARE; CATHETER, PERCUTANEOUS

Catalog Number	SK400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported during treatment of an arteriovenous malformation (avm), with admitting feeder from left superior cerebellar artery (sca) due to a bleeding episode.A non-medtronic catheter became entrapped within an onyx cast during attempted removal.Patient¿s anatomy was described as being severe and small in diameter.The non-medtronic catheter was reported to have separated resulting in the onyx to embed into an unintended location.Due to the manipulations required to remove the non-medtronic catheter a haemorrhage was noted to have occurred.It has also been reported that a gooseneck snare was used and deployed.It was reported that the gooseneck snare broke when it was pulled with force.The physician pulled the device with a strong force, but did not intend to break it.Protamine was administered to stop the bleeding and the operation was stopped for 10 minutes.Hemostasis was performed and no increase bleeding was observed.The ring shaped part of the gooseneck snare was pressed up against the blood vessel wall using a non-medtronic microcatheter and the procedure was completed.The surgical time was extended by more than 30 minutes.

• Brand Name: MICROSNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8115362
• Report Number: 2183870-2018-00546
• Device Sequence Number: 1579228
• Product Code: DQY
• UDI-Device Identifier: 00821684005026
• UDI-Public: 00821684005026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2023
• Device Catalogue Number: SK400
• Device Lot Number: A695766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR