MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION TUBING 3; DXE

Catalog Number	IST3-A
Medical Device Problem Codes	Aspiration Issue (2883); Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2015
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
The patient was undergoing a thrombectomy procedure using an indigo system aspiration tubing 3 (tubing).During the procedure, the physician noticed that the tubing was not aspirating even though the flow switch was on.The physician swapped out the tubing for a new indigo system aspiration tubing 2 and completed the procedure.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION TUBING 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5360696
• Report Number: 3005168196-2016-00050
• Device Sequence Number: 13492998
• Product Code: DXE
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/17/2015

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: 10/18/2018
• Device Catalogue Number: IST3-A
• Device Lot Number: F66071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR