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

Model Number PMX110

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

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 for a cerebral infarction in the left internal carotid artery (ica) using a penumbra system aspiration pump max 110v (pump max).During the procedure, the physician attempted to increase the pump max negative pressure; however, the negative pressure would only reach -20 inhg.It was reported that the vacuum gauge needle moved slowly.Therefore, the procedure was completed using a direct aspiration first pass technique (adapt) with the same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note the device is no longer available for return as mentioned in the initial mdr; therefore, the mdr was updated accordingly.The product was not returned for evaluation.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.The device is not available for return.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report:3005168196-2017-02188.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7109033
• MDR Text Key: 94835256
• Report Number: 3005168196-2017-02188
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/13/2017

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: Physician
• Device Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F23407-21
• Was Device Available for Evaluation?: No
• 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: 11/13/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 04/10/2018; 01/14/2005
• Supplement Dates FDA Received: 04/11/2018; 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1