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

Catalog Number PST2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Result: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Conclusion: these 2 lots were not on the production floor at the same time or in any way connected.No reprocessing was performed.Therefore these lots could not have been mixed during the processing up to and including sl release to fg.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2015-00853.The hospital saved the device for use.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max).Upon removal from the packaging, a penumbra system max aspiration tubing was found inside the box labelled for a penumbra system 3max reperfusion catheter.The procedure continued using a new 3max catheter and the aspiration tubing was saved for use at a later date.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• 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: 5040340
• MDR Text Key: 24590268
• Report Number: 3005168196-2015-00852
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012025
• UDI-Public: 00814548012025
• 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: Health Professional
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: PST2
• Device Lot Number: F63665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1