MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220; NRY

Model Number	PMX220
Medical Device Problem Codes	Decrease in Suction (1146); Device Emits Odor (1425)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2020
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.This report is associated with mfr report number: 3005168196-2020-01636.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system aspiration pump max 220 (pump max) and pump max canister (canister).It was noted that the procedure was several hours long under general anesthesia.During the procedure, several hours in and nearing the end of the procedure, the physician noticed that the top of the canister sagged under aspiration and that there was a decrease in aspiration.It was reported that the physician was able to aspirate some thrombus but not all of it.The pump max stopped working and a burning smell was noted.It was also reported that the pump max was turned on and off several times during the procedure.The procedure was completed using a new canister and the same pump max.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Results: the pump max was powered on and was able to achieve vacuum pressure within specification.The pump max was tested using a demonstration canister, and the pump max was able to achieve vacuum pressure within specification.The pump max remained powered on and no decrease in aspiration was observed and no burning smell was observed.Conclusions: evaluation of the returned pump max could not confirm the reported complaint.A demonstration canister was connected to the pump max.The pump max was powered on and was able to achieve vacuum pressure within specification.The pump max remained powered on and no decrease in aspiration was observed and no burning smell was observed.Penumbra pumps and canisters 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.This report is associated with mfr report number: 1.3005168196-2020-01636.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10631540
• Report Number: 3005168196-2020-01635
• Device Sequence Number: 16958659
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020
• 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: PMX220
• Device Catalogue Number: PMX220
• Device Lot Number: F15286-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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