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

Catalog Number	PMX110
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism (pe) using a penumbra system aspiration pump max 110v (pump max).During the procedure, after approximately 90 minutes of intermittent aspiration using the pump max, a penumbra field representative noticed that the pump max became hot and was, therefore, turned off.It was reported that it was not possible to aspirate the distal segment of the pulmonary branch.The pump max was not turned on again to prevent further damage.The procedure was ended at this point due to no additional pump maxs being available.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the power inlet was damaged on the back of the pump max.The vacuum gauge attached to the pump housing was loose.The pump max housing was cracked.Conclusion: evaluation of the returned pump max revealed that the pump was functional.During functional testing, the pump max was powered on and ran for approximately 30 minutes and generated a vacuum pressure within specification.The pump max did not get hot.The pump housing was opened and no visible damage was observed.Further evaluation of the returned pump max revealed that the power inlet and the pump housing were damaged and the vacuum gauge attached to the pump housing was loose.These damages were likely incidental to the reported complaint.Penumbra pumps are visually inspected during in-process inspection and during quality inspection after manufacturing.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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8489614
• Report Number: 3005168196-2019-00652
• Device Sequence Number: 14125549
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019
• 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: PMX110
• Device Lot Number: F06970-39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Date Report Sent to FDA: 01/01/2005