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

Model Number	CAT6
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed that the catheter was stretched.If the cat6 is forcefully retracted against resistance, damage such as stretching may occur.Further evaluation revealed distal ovalization.If the device is forcefully gripped or pinched during use, damage such as this may occur.This ovalization likely contributed to the resistance experienced during the procedure.During the functional test, the cat6 was unable to be advanced through a demonstration neuron max due to the ovalization on the catheter shaft.Further evaluation also revealed kinks in the catheter shaft.This damage was incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the brachial artery using an indigo system aspiration catheter 6 (cat6), a non-penumbra sheath, and a guidewire.During the procedure, the physician used the tip protector to introduce the cat6 to the sheath and encountered resistance.The cat6 was then removed and the physician noticed the distal tip was stretched.Therefore, the cat6 was no longer used.The procedure was completed using another cat6, the same guidewire, and the same sheath.There was no report of an adverse effect to the patient.

• 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: 11254948
• Report Number: 3005168196-2021-00184
• Device Sequence Number: 19524699
• Product Code: QEW
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021
• 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: 03/28/2022
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F89297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005