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

Catalog Number	PAPS2
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2018
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 using indigo pump max canister (canister).During the procedure, the physician connected the penumbra system aspiration pump max 110 (pump max), the aspiration tubing (tubing), the canister, and a penumbra system ace 68 reperfusion catheter (ace68), and began aspirating within the patient.While aspirating, the pump max was only able to create a suction of -10 to -15 mmhg.The physician, therefore, turned off the pump max and checked each of the connections in the system, and then re-attempted to aspirate.The pump max was still unable to create a suction greater than -10 to -15 mmhg, and the physician then noticed an air leakage sound coming from near the canister filter.The physician, therefore, completed the procedure using manual aspiration and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the distributor indicated that the device is no longer available for return.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.

• Brand Name: INDIGO PUMP MAX CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7518385
• Report Number: 3005168196-2018-00998
• Device Sequence Number: 19214670
• Product Code: DXE
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018
• 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: Physician
• Device Catalogue Number: PAPS2
• Device Lot Number: F78506
• 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: 04/16/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005