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

Catalog Number	IAPS2
Medical Device Problem Codes	Decrease in Suction (1146); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the canister was undamaged.The demonstration pump max had a vacuum of approximately -29.0 inhg while powered on with a pressure gauge attached.When attaching the canister, the demonstration pump max still had a vacuum of approximately -29.0 inhg.The pressure gauge, however, only had a vacuum of -27.5 inhg, which is within the specification for the canister.Conclusion: evaluation of the returned canister revealed an undamaged device.When functionally tested with a demonstration pump max, the canister was able to hold a vacuum pressure within specification.Penumbra canisters are inspected during incoming quality inspection.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 on the posterior tibial artery using an indigo pump max canister (canister).During the procedure, a penumbra staff noticed the vacuum produced by the penumbra system aspiration pump max (pump max) went down to -29inhg.After troubleshooting, the penumbra staff decided to replace the canister with a new one and full vacuum power was achieved.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO PUMP MAX CANISTER
• Common Device Name: FKD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8035802
• Report Number: 3005168196-2018-02171
• Device Sequence Number: 13797904
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 10/03/2018
• 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 Catalogue Number: IAPS2
• Device Lot Number: F83376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• 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: 10/03/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005