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

Catalog Number	PAPS2
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
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.This report is associated with mfr report numbers: 3005168196-2019-01437 3005168196-2019-01438 3005168196-2019-01439 3005168196-2019-01441.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the circumflex artery using an indigo system cat rx kit, an indigo pump max canister (canister), a pump max canister (canister), and a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician advanced the indigo system catrx aspiration catheter (catrx) into the target vessel, connected the pump max and initiated the aspiration; however, no vacuum was produced.Therefore, the catrx and canister were removed.The physician then placed a new catrx and canister; however, the same issue occurred.Therefore, the system was removed.The procedure was completed using another thrombectomy device.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: 8826464
• Report Number: 3005168196-2019-01440
• Device Sequence Number: 2654462
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 06/25/2019
• 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: PAPS2
• Device Lot Number: S10354
• 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: 06/25/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005