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

Catalog Number	CAT8STR85
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system aspiration catheter 8 (cat8) was kinked approximately 1.0 and 2.5 cm from the hub; the packaging tube attached to the packaging card was kinked.Conclusions: evaluation of the returned devices confirmed that both cat8 devices and both packaging tubes were kinked.This type damage likely occurred due to improper handling during removal from packaging.If the packaging tube and device are handled forcefully during removal from the packaging, damage such as this may occur.Both of the packaging tubes that were attached to the packaging cards were kinked in the same location as the damaged cat8 devices, suggesting the sustained damage occurred prior to removal of the cat8 devices from the packaging tubes.Cat8 devices are 100% 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.This report is associated with mfr report number: 3005168196-2016-00749.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff noticed that two indigo system aspiration catheter 8 devices (cat8) were kinked upon removal from the packaging.The kinked cat8 devices were found prior to use and therefore, were not used for the procedure.The procedure was completed using another manufacturer's device.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5704847
• Report Number: 3005168196-2016-00750
• Device Sequence Number: 171196
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/08/2016

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: Health Professional
• Device Expiration Date: 07/22/2018
• Device Catalogue Number: CAT8STR85
• Device Lot Number: F64994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2016
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1