MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat5 was punctured approximately 118.0 cm from the hub and an exposed coil wind was visible.The catheter had a kink approximately 17.0 cm from the hub and ovalization approximately 48.0 cm to 50 cm from the hub.Conclusions: evaluation of the returned cat5 revealed a puncture of the catheter shaft on its distal length.The complaint reported a guidewire puncturing the catheter.If the distal length of the catheter were damaged prior to the puncture, it may cause the guidewire to become stuck at this location.Forcefully advancing the guidewire against resistance likely resulted in the puncture of the catheter.The root cause of the guidewire becoming stuck at this location could not be determined.Further evaluation revealed a kink and ovalization damage along the length of the catheter.These damages were likely incidental to the reported failure.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the posterior tibial artery using an indigo system cat5 aspiration catheter (cat5).During the procedure, the physician advanced a non-penumbra guidewire through the cat5 and punctured the distal end of the cat5; therefore, the cat5 was removed.The procedure was completed using a new cat5.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8059547
• Report Number: 3005168196-2018-02242
• Device Sequence Number: 2025478
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Report Date (Section B): 10/16/2018
• 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: Health Professional
• Device Expiration Date: 04/25/2021
• Device Catalogue Number: CAT5
• Device Lot Number: F83040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• 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: 10/16/2018
• Initial Report FDA Received Date: 11/12/2018
• 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