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

Catalog Number	IST3
Medical Device Problem Codes	Complete Blockage (1094); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using indigo system aspiration tubing (tubing).During the procedure, the tubing became clogged and was unable to be used with aspiration, even after removing the flow switch to clean the tubing, and attempting to aspirate through the tubing without the rotating hemostasis valve (rhv).The physician therefore completed the procedure using a new tubing and the same indigo system cat8 aspiration catheter (cat8).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the indigo system aspiration tubing (tubing) had blood inside.The on/off flow switch was missing from the tubing.Conclusions: evaluation of the returned tubing revealed that the tubing was functional even though the flow switch was removed and not returned.The tubing was connected to a demonstration canister and aspiration pump.The aspiration pump was powered on and the tubing was used to aspirate water into the canister without an issue.Therefore, the root cause of the reported tubing being clogged and unable to aspirate could not be determined.The on/off flow switch and cat8 referred to in the complaint was not returned for evaluation.Penumbra tubing is visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASIPRATION TUBING
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7016367
• Report Number: 3005168196-2017-01903
• Device Sequence Number: 1228151
• Product Code: DXE
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 07/11/2020
• Device Catalogue Number: IST3
• Device Lot Number: F78102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1