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

Model Number	CATD-C
Medical Device Problem Codes	Material Deformation (2976); 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	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional 510(k)#s that also apply to this complaint: k160533; k161523.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occluded arteriovenous (av) fistula using an indigo system catd aspiration catheter (catd) and non-penumbra sheath.During the procedure, a pinnacle sheath was placed in the dialysis fistula.The physician then experienced resistance after advancing the catd a few centimeters through the sheath.Therefore, the physician removed the catd and noticed the distal tip to be ovalized.It was reported that the physician noticed the sheath to be kinked under fluoroscopy and the catd became damaged upon advancing through the kinked section of the sheath and, therefore, the sheath was also removed.The procedure was completed using a new catd and sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10708694
• Report Number: 3005168196-2020-01791
• Device Sequence Number: 3456996
• Product Code: QEW
• UDI-Device Identifier: 00815948020481
• UDI-Public: 00815948020481
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• 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): 09/24/2020
• 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: 01/30/2023
• Device Model Number: CATD-C
• Device Catalogue Number: CATD
• Device Lot Number: H10288
• Was Device Available for Evaluation?: No
• 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: 09/24/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005