MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 3 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	06/18/2018
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 peroneal artery using an indigo system cat3 aspiration catheter (cat3).During the procedure, after removing the clot from the target vessel using a cat3 and a non-penumbra sheath , the physician removed the cat3 to take an angiogram.Upon removal, it was noticed that the cat3 was almost cut in half.The procedure was completed by administering tissue plasminogen activator (tpa) for a second night due to suboptimal results.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was lost.Therefore, without the return of the device, the root cause of the problem cannot be determined.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 peroneal artery using an indigo system cat3 aspiration catheter (cat3).During the procedure, after removing the clot from the target vessel using a cat3 and a non-penumbra sheath, the physician removed the cat3 to take an angiogram.Upon removal, it was noticed that the cat3 was almost cut in half.The procedure was completed by administering tissue plasminogen activator (tpa) for a second night due to suboptimal results.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7692327
• Report Number: 3005168196-2018-01379
• Device Sequence Number: 19062625
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 06/18/2018
• 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: 12/11/2020
• Device Catalogue Number: CAT3
• Device Lot Number: F80965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 03/07/2019
• 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