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

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	07/16/2021
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.This report is associated with mfr report number: 3005168196-2021-01785, 3005168196-2021-01786.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal and posterior tibial using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, while inserting a cat6 using a peel-away sheath into the sheath, the physician experienced resistance.Subsequently, the physician stretched and ovalized the distal tip of the cat6; therefore, the cat6 was removed.The physician then completed one pass using a new cat6 that removed some clot.Afterwards, while re-inserting the cat6 through the peel-away sheath, the physician experienced resistance at the distal tip of the cat6.Subsequently, the physician kinked the cat6; therefore, the cat6 was removed.Then, while attempting to advance a penumbra system ace 68 reperfusion catheter (ace68) through the sheath, the physician experienced resistance.Subsequently, the physician ovalized the distal end of the ace68.Therefore, the ace68 and sheath were removed.The procedure was completed using a new cat6 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up: 1.Section d.Box 10.Device available for evaluation? additional information: please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 10/01/2021: 1.Section h.Box 3.Reason for non-evaluation.1.Section h.Box 3.''other'' reason for non-evaluation.1.Section h.Box 6.Method code 1.1.Section h.Box 6.Method code 2.1.Section h.Box 6.Method code 3.1.Section h.Box 6.Results code 1.1.Section h.Box 6.Conclusions code 1.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12307585
• Report Number: 3005168196-2021-01784
• Device Sequence Number: 3670825
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021
• 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: 08/26/2023
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F99814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005