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

Model Number	PMX220
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2021
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 in the m1 segment of the middle cerebral artery (mca) using a penumbra system aspiration pump max 220 (pump max) and a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, the physician advanced the ace60 into the target vessel and started aspiration with the pump max using adapt technique.However, the physician was unable to aspirate the thrombus.Subsequently, it was noted that the pump max only generated aspiration pressure between -20 inhg to -25 inhg regardless of adjusting the knob to the maximum setting.To troubleshoot, the aspiration tubing and penumbra canister were checked but no leakage was observed.The procedure was completed using the current negative pressure the pump max was generating, a syringe, the same ace60 and a non-penumbra stent retriever there was no report of an adverse effect to the patient.It was also reported that after the procedure, it was noted that the negative pressure of the pump max was -25 inhg without the canister.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was sent out for return; however, has not been received by the manufacturer.Therefore, without the return of the device, the root cause of the problem cannot be determined.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: 11595647
• Report Number: 3005168196-2021-00644
• Device Sequence Number: 17012745
• 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): 03/03/2021
• 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: F46558-17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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