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

Model Number	PAPS2
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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 middle cerebral artery (mca) using a penumbra max canister (canister).During the procedure, the physician noticed that the tubing connected to the filter of the penumbra system aspiration pump max 110 (pump max) had blood in it; therefore, the canister was removed.The procedure was completed using another canister and the same pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: blood was within the canister and the canister tubing.The filter in the canister lid was covered with blood.Conclusions: evaluation of the returned canister confirmed that blood was within the canister tubing.Further investigation revealed that the canister lid filter was covered in blood.Although blood was aspirated into the canister tubing past the canister lid filter, the in-line filter worked as intended.Blood was kept from entering the pump max.The root cause of blood being aspirated past the canister lid filter could not be determined.Penumbra canisters are visually inspected and functionally tested during incoming quality inspection.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.Section h.Box 6.Results code 1: 4247 - the investigation confirmed that blood was within the canister tubing.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of blood being aspirated past the canister lid filter.

• Brand Name: PUMP MAX CANISTER
• Common Device Name: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9407007
• Report Number: 3005168196-2019-02230
• Device Sequence Number: 1711362
• Product Code: JCX
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122756
• 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,Followup
• Report Date (Section B): 11/07/2019
• 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 Model Number: PAPS2
• Device Catalogue Number: PAPS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 03/01/2020
• 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