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

Catalog Number PMX110

Device Problems Low Readings (2460); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The patient was undergoing a thrombectomy in the middle cerebral artery (mca) using a penumbra system aspiration pump max 110v (pump max).During the procedure, while in use with a penumbra system 5max ace reperfusion catheter (5max ace), the sound of the pump max motor became smaller and the pressure indicated by the meter on the motor was decreasing while the devices were continuously aspirating thrombus.The physician had to restart the pump max several times during the procedure but it was eventually completed using the same pump max and 5max ace.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Describe event or problem on the initial mfr report indicated that "the physician had to restart the pump max several times during the procedure but it was eventually completed using the same pump max and 5max ace." however, additional clarification provided by the distributor on 10/04/2016 indicated that the physician did not restart the pump max multiple times throughout the procedure.The procedure was eventually completed using the same pump max and 5max ace without additional steps.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5990341
• MDR Text Key: 56034035
• Report Number: 3005168196-2016-01394
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F12110-39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 89 YR