MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM FLASH ASPIRATION CATHETER; QEW

Catalog Number	LITNGFHT115BER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure using an indigo system flash aspiration catheter.During the procedure, post first clot removal the patient experienced supra ventricular tachycardia (svt).Then the heart rate (hr) decreased (bradycardia) from 152 to 66 beats per minute (bpm), systolic blood pressure (bp) decreased from 134 mmhg to 109 mmhg which was likely a vagal episode.The event resolved with hr at 109 bpm.Atropine was administered and thrombus removal was continued.Svt was unrelated to the indigo system.Bradycardia was reported to be an adverse event with a possible relationship to the indigo system and a possible relationship to the index procedure.The event is considered resolved.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, the device is not available for return.The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.From the information provided, there is no indication that there was any device malfunction, non conformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM FLASH ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20141482
• Report Number: 3005168196-2024-00302
• Device Sequence Number: 3226376
• Product Code: QEW
• UDI-Device Identifier: 00815948029453
• UDI-Public: 00815948029453
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K240030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024
• Report Date (Section F): 01/01/2005

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00010054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005