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

Model Number	CAT6
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
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 sheath.During the procedure, the cat6 was noticed to be kinked at the midshaft and distal end after the first aspiration.Therefore, the cat6 was not for the remainder of the procedure.The procedure was completed with ballooning.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed kinks on the midshaft and distal end.If the device is forcefully manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as kinks may occur.During functional testing, the cat6 was unable to be advanced through a demonstration rhv due to the damage on the distal shaft.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 ASPIRATION CATHETER 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11953385
• Report Number: 3005168196-2021-01272
• Device Sequence Number: 1376812
• Product Code: QEW
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter Country: MU
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• 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: 12/16/2021
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F87552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/07/2021
• 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
• Date Report Sent to FDA: 01/01/2005