MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 BOSS BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number 100240

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

Patient Problems Extravasation (1842); Intracranial Hemorrhage (1891)

Event Date 08/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that a solitaire procedure was complicated by extravasation/subarachnoid hemorrhage (sah) in the region of the left m2/m3 junction promptly controlled with temporary balloon occlusion.It was reported that during a solitaire procedure there was an extravasation near the m2/m3 junction.The boss balloon was inflated in the cervical ica for 1-2 minute intervals.Multiple intermittent angiograms were performed.After approximately 4-5 minutes, the angiogram demonstrated no further active extravasation.There was successful tici 3 recanalization of left m2 mca occlusion status post transarterial mechanical embolectomy. dynact of the head was performed, demonstrating subarachnoid hemorrhage in the left sylvian fissure and sulcal extension cranially and caudally.There was no significant midline shift.The patient's vital signs remained stable throughout the procedure.At the end of the procedure the patient's pupils were equal and reactive bilaterally.The patient was admitted to icu for further management.Their nihss score was 22.The patient was still hospitalized 7 days after the procedure.The event was assessed as related to the procedure and not related to the device.Ancillary devices include a sofia 5 catheter, headway 27 microcatheter, and aristotle 24 microwire.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Additional information was received indicating the patient was transferred to the icu post-procedure in stable condition and discharged from the hospital on (b)(6) 2021.The event promptly resolved during the procedure and no further patient symptoms were reported.

• Brand Name: BOSS BALLOON GUIDE CATHETER
• 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: 13007047
• MDR Text Key: 286503386
• Report Number: 2029214-2021-01615
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100240
• Device Catalogue Number: 100240
• Device Lot Number: 901759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female