MAUDE Adverse Event Report: REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2021-01303 for the pipeline involved in this event and manufacturer report # 2029214-2021-01304 for the solitaire involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline failed to open in the middle.The patient was undergoing treatment for a ruptured aci fistula.The patient's vessel tortuosity was severe.The landing zone was 4.3mm distal and 4.6mm proximal.The access vessel was the avi.It was reported that a thrombectomy with a rebar 18 catheter and solitaire was performed.It was likely that plaque was moved with the pull back, and the patient got a sinus cavernous fistula.The doctor decided to use a flow diverter to cover the fistula.They tried for over two hours to open the pipeline fully, but it was not possible.Eventually the pipeline became stuck in the phenom catheter.The pipeline was positioned in a bend, and more than 50% had been deployed when in failed to open.The pipeline had been resheathed more than 2 times.They removed both devices, and a replacement pipeline was used successfully with some difficulty.Angiographic results showed that everything was fine after using the second pipeline. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a sofia 6f guide catheter and a traxcess guidewire.

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.

Event Description

Additional information was received indicating the physician attempted to resheath several times.There was no balloon used, once it was not possible to move the pipeline.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• MDR Report Key: 12661124
• MDR Text Key: 278113177
• Report Number: 2029214-2021-01306
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• 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
• Patient Age: 81 YR