MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Model Number	CAT3-A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal and posterior artery using an indigo system cat3 aspiration catheter (cat3) and indigo system separator 3 (sep3).It was reported that a stent was placed in the superficial femoral artery (sfa) a few days prior to the procedure, and after the stent placement, the vessels below-the-knee (btk) were found occluded.During the procedure, while inserting the sep3 into the cat3, the physician noticed under fluoroscopy that the sep3 was lying next to the cat3 instead of being advanced through the cat3.It was concluded there was a hole somewhere on the cat3.Therefore, the cat3 and sep3 were removed.The procedure was completed using another cat3 and the same sep3.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10248672
• Report Number: 3005168196-2020-00903
• Device Sequence Number: 2426283
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/16/2020
• 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: 11/05/2020
• Device Model Number: CAT3-A
• Device Catalogue Number: CAT3
• Device Lot Number: F80364
• 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: 06/16/2020
• Initial Report FDA Received Date: 07/08/2020
• 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