MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT8 ASPIRATION CATHETER; QEW

Catalog Number	CAT8XTORQ115
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient underwent a successful thrombectomy procedure in the left brachial artery using an indigo system cat8 aspiration catheter (cat8), a penumbra system ace 60 reperfusion catheter (ace60), a non-penumbra sheath, a balloon dilatation catheter and a guidewire.A final angiogram was performed and identified a metal piece in the radial artery.It is unknown where the metal piece had come from.Upon removal of the cat8, the physician noticed that the distal end of the cat8 was peeled off.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat8 confirmed that the markerband was detached and revealed discoloration and damage to the material on the distal end of the catheter.Based on the reported complaint, the root cause of this damage could not be determined.The damage to the material on the distal end of the cat8 may have contributed to the markerband detaching from the catheter.Further evaluation revealed a kink on the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 CAT8 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: 17386825
• Report Number: 3005168196-2023-00350
• Device Sequence Number: 20397978
• Product Code: QEW
• UDI-Device Identifier: 00815948022300
• UDI-Public: 815948022300
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: H00000515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005