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

Catalog Number	IST3-A
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2016
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 for a deep vein thrombosis (dvt) using the indigo system aspiration tubing (tubing).During the procedure, no aspiration was possible.The tubing was removed and attempts to aspirate saline were unsuccessful.The procedure was completed using new tubing.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the indigo system aspiration tubing (tubing).Coagulated blood was flushed out of the tubing during decontamination by a penumbra investigator.The tubing was connected to an aspiration pump.The aspiration pump was powered on and vacuum was present.Conclusions: evaluation of the returned device revealed that the tubing was functional.During decontamination, coagulated blood was flushed out of the tubing by a penumbra investigator.The tubing was connected to an aspiration pump and vacuum was present.Therefore, the tubing was functional.The coagulated blood likely contributed to no aspiration.Tubing is visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASPIRATION TUBING
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5563554
• Report Number: 3005168196-2016-00462
• Device Sequence Number: 10840205
• Product Code: DXE
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR