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

Catalog Number	IST3-A
Medical Device Problem Codes	Suction Problem (2170); Defective Component (2292); Out-Of-Box Failure (2311); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/07/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5401804
• Report Number: 3005168196-2016-00125
• Device Sequence Number: 505155
• Product Code: NRY
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 10/26/2018
• Device Catalogue Number: IST3-A
• Device Lot Number: F66191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1