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

Catalog Number PAPS2

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

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 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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8826464
• MDR Text Key: 152203839
• Report Number: 3005168196-2019-01440
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,06/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: PAPS2
• Device Lot Number: S10354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR