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

Model Number PMX220

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the internal iliac artery (iia) using a penumbra system aspiration pump max 220 (pump max) and an indigo system aspiration catheter 6 (cat6).During the procedure, the physician completed a pass using the cat6 and pump max.Next, the physician removed the cat6 and the pump max was turned off.Afterwards, the physician advanced the cat6 for another pass and turned on the pump max.However, the pump max would not turn on.Subsequently, the pump max turned on after several attempts were made.The procedure was completed using the same pump max and the same cat6.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2021-00630 1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device.Evaluation of the returned pump max revealed a functional device.During the functional testing, the pump max was able to power on and produce a vacuum pressure within specification.The pump was turned on and turned off several times and no issue found.The reported complaint could not be determined.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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11586515
• MDR Text Key: 242976670
• Report Number: 3005168196-2021-00630
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/01/2021

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
• Device Operator: Health Professional
• Device Model Number: PMX220
• Device Catalogue Number: PMX220
• Device Lot Number: F23626-17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1