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

Model Number	PMX110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal artery, posterior tibial artery and the peroneal artery using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician discovered the control knob to be loose; however, the procedure was completed using the same pump max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the regulator knob was loose and unable to turn the vacuum power up or down.During functional analysis, the pump max was able to power on and produced a vacuum pressure of approximately -29.0 inhg.The regulator knob was unable to adjust vacuum pressure.Conclusions: evaluation of the returned pump max confirmed a loose regulator knob.If the regulator knob is over rotated, the hex nut that secures the regulator knob to the device housing may loosen.If the regulator knob is loosened, the regulator knob may not function properly.During functional testing, the pump max was able to power on and produce a vacuum pressure within specification, but the regulator knob was unable to adjust vacuum pressure.Penumbra pumps are 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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 02 mfr report:3005168196-2019-00900 1.Section d.Box 4.Serial # please note that the following section was inadvertently missed on the follow-up # 01 mfr report:3005168196-2019-00900 and is being updated on this follow-up # 02 mfr report:3005168196-2019-00900 2.Section h.Box 6.Additional results code h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8591112
• Report Number: 3005168196-2019-00900
• Device Sequence Number: 19406450
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2019
• 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 Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F35278-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/03/2019; 01/14/2005
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/28/2019; 10/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005