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

Model Number	CAT6KIT-A
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2021
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.
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 and guidewire.During the procedure, the physician used the cat6 with the sheath and guidewire to access the tibial artery.When removing the cat6 from the tibial artery on the first pass, the physician experienced resistance, and the distal tip of the cat6 stretched.It was reported that no guidewire was used on removal so as to not dislodge any clot.The procedure was completed using a new cat6 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 was stretched and ovalized.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of resistance could not be determined.Further evaluation of the device revealed kinks and ovalizations throughout the length of the catheter.This damage was incidental to the reported complaint and may have occurred during removal from the procedure or packaging for return for penumbra.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: 12088995
• Report Number: 3005168196-2021-01438
• Device Sequence Number: 17019866
• Product Code: QEW
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K180105
• 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): 06/29/2021
• 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: 02/25/2024
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F104169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005