MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO PUMP MAX CANISTER; DXE

Catalog Number	IAPS2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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 iliac vein using an indigo pump max canister (canister).During the procedure, the physician was using the penumbra system pump max 110v (pump max) to aspirate and noticed that the canister began filling with foam.The penumbra sales representative (representative) disconnected and reconnected the aspiration tubing several times in order to depressurize the canister and allow the foam to recede.Due to this, the representative decided to replace the canister as this process was beginning to interrupt the procedure.The procedure was completed using another canister.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO PUMP MAX CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8364679
• Report Number: 3005168196-2019-00349
• Device Sequence Number: 2287603
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 01/25/2019
• 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 Catalogue Number: IAPS2
• Device Lot Number: F85015
• Was Device Available for Evaluation?: No
• 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: 01/25/2019
• Initial Report FDA Received Date: 02/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005