MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, PERCUTANEOUS

Model Number FG19120-1030-1S

Device Problems Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the doctor reported that after deployment of the pipeline device he attempted to angioplasty the distal end to improve opening and arterial wall apposition.He also attempted to deploy an atlas stent to open the distal end.Multiple passes and tortuous anatomy.The doctor reported that at some point he noticed that the distal marker band of the phenom plus had become detached from the catheter and remained in the pipeline.He attempted to retrieve the catheter marker band with a 3x20 solitaire device (sfr4-3-20-10).The solitaire opened the pipeline but the marker band was notretrieved.It was noted that catheter separation/break occurred during use.There was no friction or difficulty during injection.The catheter tip was entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.Surgical or medicinal intervention was required as the surgeon attempted to retrieve the marker band with a solitaire stent retriever.The marker band remained in the vessel.The broken location was on the distal end.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).It was noted the patient's vessel tortuosity was severe.The access vessel was the radial artery.Ancillary devices include a phenom 27 150cm length microcatheter and a guidewire.

• Brand Name: CATHERA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16985357
• MDR Text Key: 315779308
• Report Number: 2029214-2023-00831
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG19120-1030-1S
• Device Catalogue Number: FG19120-1030-1S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• 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): Required Intervention