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

Catalog Number PMX110

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

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 hospital disposed of the device as a medical waste.

Event Description

The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system aspiration pump max 110 (pump max).During the procedure, the medical assistant accidentally misconnected the max aspiration tubing (tubing) directly to the pump max without using the canister.Consequently, upon initiating aspiration, blood directly flowed into the pump max.The physician was able to complete the procedure using the same pump max as it was connected.There was no report of an adverse effect to the patient.

• 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: 6015758
• MDR Text Key: 56972149
• Report Number: 3005168196-2016-01435
• 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
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F18683-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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