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

Model Number	PMX220
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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 using a penumbra system aspiration pump max 220 (pump max) and a penumbra system ace 68 reperfusion catheters (ace68).During the procedure, the pump max aspiration pressure would not increase beyond -20 inhg resulting in the decrease of suction force for the thrombus; therefore, the pump max was removed.It was reported that multiple attempts were made to troubleshoot the pump max but were unsuccessful.The procedure was completed using manual aspiration with a 60cc syringe.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: a pipe cleaner was inserted into the vacuum inlet, and blood was observed inside the tubing.Conclusions: evaluation of the returned pump max revealed blood within the tubing.If the aspiration tubing is connected directly to the vacuum inlet instead of a canister, supplied by penumbra, blood may be aspiration into the pump assembly.If this occurs, the pump max may not function properly.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 220
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9832356
• Report Number: 3005168196-2020-00362
• Device Sequence Number: 740385
• Product Code: NRY
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020
• 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: F20889-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005