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

Catalog Number	CAT8XTORQ115
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
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
During preparation for a medical procedure, it was reported that an indigo system aspiration catheter 8 (cat8) was found to be kinked mid-shaft after removal from the packaging, while passing the cat8 to the table.The damage to the cat8 was found prior to use and therefore was not used in the procedure.The procedure was completed using another cat8.
Additional Manufacturer Narrative
Results: the returned cat8 was kinked at approximately 55.0 cm from the hub.The device was ovalized at approximately 64.0 cm, 73.0 cm, 74.0 cm and 79.0 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed a kink at its mid shaft.If the device was forcefully retracted at extreme angles from its packaging or otherwise mishandled, damage such as a kink may occur.Further investigation revealed that returned cat8 had ovalizations on its distal shaft.These damages were likely incidental to the complaint.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.

• 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: 8489249
• Report Number: 3005168196-2019-00651
• Device Sequence Number: 19314748
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019
• 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: 01/17/2021
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F81485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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