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	02/10/2021
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 anterior tibial artery using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, while inserting the cat6 into the sheath, the physician experienced resistance.Subsequently, the physician kinked the distal end of the cat6.Therefore, the cat6 was removed.The procedure was completed using a non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed that the catheter was kinked.If the peel-able sheath is not used to protect the distal shaft of the cat6 during insertion, damage such as kinks may occur.During the functional test, resistance was encountered due to the kinks and ovalization on the distal shaft of the cat6 while attempting to advance the catheter through a demonstration neuron max, and the cat6 could not be advanced any further.Further evaluation revealed additional ovalization along the distal shaft.This damage was incidental to the reported complaint and may have occurred during forceful gripping or pinching during insertion.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.

• 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: 11437818
• Report Number: 3005168196-2021-00425
• Device Sequence Number: 11542536
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 02/10/2021
• 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: 12/02/2022
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F94622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005