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

Catalog Number PMX110

Device Problems Incorrect Measurement (1383); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 110 (pump max).The pump was powered on and was confirmed to aspirate to specification of -25inhg.The vacuum gauge was tested to be within specification by using a calibrated vacuum gauge.Conclusions: evaluation of the returned device revealed that upon powering on, the pump was confirmed to aspirate to specification of -25inhg.In addition, the vacuum gauge was tested to be accurate using a calibrated vacuum gauge.The root cause of this complaint could not be determined.These devices are 100% functionally tested during inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, it was reported that the pump max produced adequate vacuum; however, the regulator knob (gauge) was not registering the pressure correctly, it read -18 inhg instead of -20 inhg.The procedure continued using the same pump max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5138114
• MDR Text Key: 27906193
• Report Number: 3005168196-2015-01001
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/09/2015

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 Catalogue Number: PMX110
• Device Lot Number: F07760-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR