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

Model Number	CAT6
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath.During the procedure, the physician advanced the cat6 with the peel away sheath up and over into the contra lateral sfa.It was reported the physician had experienced resistance while advancing the cat6 through the sheath.When the cat6 met the clot, the cat6 kinked at the distal end.Therefore, the cat6 was removed.The procedure was completed using an indigo system aspiration catheter 7 (cat7) and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed that the distal shaft of the catheter was kinked.If the cat6 is forcefully advanced against resistance, damage such as kinks may occur.The root cause of resistance could not be determined.Further evaluation revealed that the distal shaft was stretched and ovalized.This damage was incidental to the reported complaint and may have occurred during removal of the device.During the functional test, the sep6 was unable to be removed from the cat6 after the catheter was flushed.The cat6 could not be advanced through a demonstration neuron max due to the distal shaft damage.Penumbra catheters are visually 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 ASPIRATION CATHETER 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11859459
• Report Number: 3005168196-2021-01106
• Device Sequence Number: 14548073
• Product Code: QEW
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021
• 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: 10/01/2023
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F100738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 81
• Date Report Sent to FDA: 01/01/2005