MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number CAT8XTORQ115

Device Problems Device Slipped (1584); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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 number: 3005168196-2017-01461.The hospital disposed of the device.

Event Description

During preparation for a thrombectomy procedure, the indigo system separator 8 (sep8) and indigo system aspiration catheter 8 (cat8) slipped off the table and became contaminated.The sep8 and cat8 became contaminated prior to use and therefore, were not used for the procedure.The procedure was completed using a new sep8 and cat8.

Manufacturer Narrative

Please note that section pma/510(k) was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6828851
• MDR Text Key: 83987150
• Report Number: 3005168196-2017-01462
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F74499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1