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

Catalog Number PMX110

Device Problems Device Contamination with Body Fluid (2317); Device Handling Problem (3265); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

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 anterior tibial artery using a penumbra system aspiration pump max 110v (pump max).During the procedure, the aspiration tubing was directly connected to the pump max and consequently, a small amount of blood entered inside the pump max.After that, the physician noticed that the pump max was making an unusual sound; therefore, the physician decided to stop using the pump max.The procedure was completed using another manufacturer¿s catheter to drip thrombolytics overnight.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: a pipe cleaner was inserted into the pump max vacuum port, and blood was observed to be inside the pump.Conclusions: evaluation of the returned device confirmed that blood was inside the pump max.If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly.The pump max was not functionally tested during the functional analysis.Penumbra pumps are visually and functionally inspected during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report.Device manufacture date.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6483569
• MDR Text Key: 72555278
• Report Number: 3005168196-2017-00576
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F23878-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 113