MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Catalog Number	CAT3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
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 superficial femoral artery (sfa) using an indigo system cat3 aspiration catheter (cat3).During the procedure, the physician completed the first pass using a cat3 and a non-penumbra sheath, then removed the cat3 for cleaning as it was not aspirating well.While removing the cat3 from the sheath, the physician noticed that the distal end of the cat3 was broken.Therefore.The procedure was completed using an indigo system cat5 aspiration catheter (cat5) and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat3 was kinked approximately 36.0 cm and 57.5 cm from the hub.The cat3 was fractured approximately 119.0 cm from the hub.The cat3 was ovalized approximately 134.5 cm, 141.5 cm, 143.0 cm, 145.5-146.0 cm, 147.5 cm and 148.5-149.0 cm from the hub.Conclusion: evaluation of the returned cat3 revealed distal catheter damage.If the cat3 is forcefully manipulated during attempts to advance into a parent vessel it may become ovalized.These ovalizations may contribute to difficulty advancing the device within patient anatomy.Further kinks may have been a result of forcefully advancing the device against resistance.These damages may have contributed to the difficulty aspirating experienced during the procedure.Further evaluation revealed the device was fractured.This damage typically occurs due to forcefully retracting the device against resistance.If the rhv was overtightened during retraction this may have contributed to the device fracture.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 CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7979175
• Report Number: 3005168196-2018-02060
• Device Sequence Number: 13795269
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018
• 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: 08/14/2020
• Device Catalogue Number: CAT3
• Device Lot Number: F78700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005