MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; QEW

Model Number	CAT6KIT-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01634.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal and anterior tibial artery using an indigo system aspiration catheter 6 (cat6) and indigo system catrx aspiration catheter (catrx).During the procedure, the cat6 was observed to be kinked midshaft upon removal after multiple passes were made through the peroneal and anterior tibial artery.Subsequently, the catrx also kinked midshaft upon removal after multiple passes through anterior tibial artery.It was reported that at least five to six passes were successfully made with both devices prior to kinking.The procedure was completed using a new cat6.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed a kink in its mid-shaft.If the device is forcefully mishandled at an extreme angle during removal, damage such as a kink may occur.Further evaluation of the device revealed additional kinks and ovalizations throughout its distal shaft.Based on the reported complaint, this damage was likely incidental.During functional testing, the cat6 was able to advance through a demonstration neuron max with resistance due to the kinks and ovalization in its distal shaft.Evaluation of the returned catrx confirmed a kink in its mid-shaft.If the device is forcefully mishandled at an extreme angle during removal, damage such as a kink may occur.Further evaluation of the device revealed that the guidewire lumen was damaged at its proximal end.This damage was likely incidental to the complaint.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.This report is associated with mfr report number: 1.3005168196-2021-01634 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12213175
• Report Number: 3005168196-2021-01633
• Device Sequence Number: 3130523
• Product Code: QEW
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021
• 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: 03/07/2024
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F104429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 98
• Date Report Sent to FDA: 01/01/2005