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

Catalog Number	CAT5
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
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
The patient was undergoing a thrombectomy procedure in the popliteal and tibioperoneal trunk using an indigo system cat5 aspiration catheter (cat5).During the procedure, the physician was unable to aspirate with the cat5 and upon further inspection a kink was found in the mid shaft of the cat5; therefore, it was removed.The procedure was completed using an indigo system aspiration catheter 6 (cat6).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned device had kinks at approximately 53.0 cm and 67.0 cm from the hub.The returned cat5 had ovalizations at approximately 120.0 cm, 121.0 cm and 126.0 cm from the hub.Yield marks were present on either size of the 53.0 cm kink.Air was flushed through the catheter and a leak was confirmed at the kink 53.0 cm from the hub.Conclusions: evaluation of the returned cat5 confirmed a kink on the midshaft of the device that was leaking air.Yield marks were present on either side of this kink indicating the catheter was bent.If the device mishandled and becomes bent during preparation, damage such as this may occur.If the kink is further manipulated it may worsen to eventually allow air to leak from the catheter lumen.The leak at this kink likely contributed to the inability to aspirate.Further evaluation revealed kinks and ovalizations along the catheter shaft.Some of these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 CAT 5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8179557
• Report Number: 3005168196-2018-02457
• Device Sequence Number: 1734240
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/19/2018
• 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: 03/27/2020
• Device Catalogue Number: CAT5
• Device Lot Number: F75217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005