MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V; NRY

Catalog Number PMX110

Device Problems Suction Problem (2170); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

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.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max).During the procedure, the physician connected a penumbra system ace 68 reperfusion catheter (ace68) to a pump max and started the aspiration.The physician then turned off the pump max and attempted to turn the regulator knob counterclockwise but experienced resistance.The physician then turned the knob counterclockwise forcibly against resistance.Upon turning the pump max on again, it was confirmed that the vacuum pressure would not reach the maximum.The procedure was completed using the same pump max and ace68.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7987242
• MDR Text Key: 124513689
• Report Number: 3005168196-2018-02061
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/20/2018

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: PMX110
• Device Lot Number: F14222-01
• Was Device Available for Evaluation?: No
• 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: 09/20/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1