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

Model Number PMX110

Device Problem Decrease in Suction (1146)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the popliteal vein using a penumbra system aspiration pump max 110 (pump max).During the procedure, it was reported that the flow through the indigo system aspiration catheter 8 (cat8) and into the indigo pump max canister (canister) was very slow.The physician then found that the pump max was unable to produce maximum aspiration and was only able to reach -18 in hg.Therefore, the physician decided to remove the pump max from the procedure.The procedure was completed using a new pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: a rattling noise was observed while handling the pump max and, upon inspection of the bottom of the pump, one of the screw ports was observed to be damaged and the screw was missing.Conclusions: evaluation of the returned pump max revealed a functional device.During functional testing, the pump max was powered on and was able to achieve vacuum pressure within specification.The reported complaint could not be confirmed.Further evaluation revealed a rattling noise within the pump max that was determined to be a missing screw from the bottom of the pump.This damage was likely incidental to the reported complaint and may have occurred during an attempt to open the pump¿s housing.No other devices associated with the complaint were returned for evaluation.Penumbra pumps are 100% visually inspected and functionally tested during incoming quality inspection.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 110
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9273207
• MDR Text Key: 164907476
• Report Number: 3005168196-2019-02044
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• 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: 01/01/2005,10/07/2019

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 Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F06970-36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• 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: 10/07/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR