MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Codes	Kinked (1339); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat5 was kinked approximately 119.0, 119.5, 120.0, 121.5, 122.0, 122.5 cm from the hub.The cat5 was ovalized approximately 119.5-120.0 and 120.0-121.5 cm from the hub.Conclusions: evaluation of the returned cat5 revealed a kinked device.If the peel-able sheath supplied by penumbra is not used during insertion of the cat5 into the valve of a sheath, damage to the distal tip such as kinking may occur.Further evaluation revealed multiple ovalizations on the device.If the device is forcefully gripped or pinched while advancing the device into a non-penumbra sheath, it may contribute to the catheter damage observed.During functional testing, a mandrel was attempted to be advanced through the cat5 and was unable to be advanced further when encountering the kink in the catheter.Additional functional testing of the returned cat5 revealed that water was able to aspirate through the catheter.It is likely this aspiration was not sufficient due to the catheter damage.No other devices associated with the complaint were returned for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system cat5 aspiration catheter (cat5).During the procedure, the physician placed a non-penumbra sheath, then advanced a cat5 through the sheath.After turning the aspiration on, no flow was observed and after attempting two passes with no flow, the cat5 was removed.Upon removal, it was noticed that the tip of the cat5 was kinked.The procedure was completed using a new cat5 and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7657361
• Report Number: 3005168196-2018-01324
• Device Sequence Number: 10794587
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018
• 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: Physician
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: CAT5
• Device Lot Number: F82429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 12/10/2019
• 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