MAUDE Adverse Event Report: PENUMBRA, INC. IST3 INDIGO SYSTEM ASPIRATION TUBING; NRY

Catalog Number IST3-A

Device Problems Suction Problem (2170); Defective Component (2292); Out-Of-Box Failure (2311); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2016

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.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that the flow switch on the ist3 indigo system aspiration tubing (tubing) was not working properly.The tubing was connected to a penumbra system pump max 110v (pump max) and the pump max was switched on; however, there was no suction at the distal tip.The defective tubing was found prior to use and was not used for the procedure.The procedure successfully continued using a new tubing.

• Brand Name: IST3 INDIGO SYSTEM ASPIRATION TUBING
• Type of Device: NRY
• 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: 5401804
• MDR Text Key: 37238997
• Report Number: 3005168196-2016-00125
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

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 Expiration Date: 10/26/2018
• Device Catalogue Number: IST3-A
• Device Lot Number: F66191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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