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

Catalog Number	PAPS2
Medical Device Problem Codes	Break (1069); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
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 m1 segment of the middle cerebral artery (mca) using a pump max canister (canister) and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the physician was aspirating in the target vessel using the ace68 and noticed that aspiration had decreased.Subsequently, a crack on the lid of the canister was found.Therefore, the canister was removed.The procedure was completed using a new canister and the same ace68.There was no report of an adverse effect to the patient.

• Brand Name: PUMP MAX CANISTER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9527658
• Report Number: 3005168196-2019-02415
• Device Sequence Number: 13555838
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019
• 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: PAPS2
• Device Lot Number: S10549
• 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: 12/04/2019
• Initial Report FDA Received Date: 12/27/2019
• 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