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

Catalog Number	IST3-A
Medical Device Problem Codes	Contamination (1120); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2016
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.This report is associated with mfr report numbers: 3005168196-2016-00865; 3005168196-2016-00867.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using indigo system aspiration catheter 6 (cat6) devices and an indigo system aspiration tubing (tubing).During preparation for the procedure, while the tubing packaging was being opened, part of the tubing popped out and was contaminated by a non-sterile hand.The tubing was contaminated prior to use and therefore, was not used for the procedure.A new tubing was then opened for the procedure.During the procedure, while attempting to advance the cat6 through another manufacturer's sheath, the physician inadvertently kinked the cat6.The kinked cat6 was then removed and a new cat6 was opened.The physician did not report any resistance, friction or difficulty while advancing the first cat6.However, while attempting to advance the second cat6 through the same sheath, the physician met resistance.At this point, the physician suspected that the sheath was kinked and decided to discontinue use of the penumbra devices and place a lytic catheter in the patient instead.The second cat6 was removed and another manufacturer's lytic catheter was opened.The physician had difficulty placing the catheter and encountered resistance, but ultimately got the catheter placed in the patient and completed the procedure.There was no report of adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report.Patient identifier.Sex.This report is associated with mfr report number: 3005168196-2016-00865; and 3005168196-2016-00867.

• Brand Name: INDIGO SYSTEM ASPIRATION TUBING
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5746613
• Report Number: 3005168196-2016-00866
• Device Sequence Number: 219
• Product Code: DXE
• UDI-Device Identifier: 00814548016221
• UDI-Public: 00814548016221
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2016
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 11/19/2018
• Device Catalogue Number: IST3-A
• Device Lot Number: F66594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005