MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8TORQ85KIT-B
Medical Device Problem Codes	Suction Problem (2170); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
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 femoral vein using an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the physician inserted the cat8 into the sheath using the peel-away sheath.While aspirating with the cat8, it became clogged and the physician decided to remove it.Upon removal, it was noticed that the tip of the cat8 was ovalized.The procedure was completed using a non-penumbra thrombectomy system and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat8 was kinked approximately 15.0 cm from the hub.The cat8 was ovalized approximately 58.0 and 81.0 thru 84.5 from the hub.Conclusions: evaluation of the returned cat8 confirmed that the distal shaft of the catheter was ovalized.If the peel-able sheath is not properly used to protect the distal shaft of the cat8 during insertion, damage such as ovalization may occur.Further evaluation of the cat8 revealed additional ovalization and a kink.This damage was likely incidental to the reported complaint.Penumbra catheters are visually 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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10451071
• Report Number: 3005168196-2020-01277
• Device Sequence Number: 3316997
• Product Code: DXE
• UDI-Device Identifier: 00815948022508
• UDI-Public: 00815948022508
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/04/2020
• 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: CAT8TORQ85KIT-B
• Device Catalogue Number: CAT8TORQ85KIT
• Device Lot Number: C20981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005