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

Catalog Number	CATD
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2017
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
During preparation for a thrombectomy procedure, the hospital staff found that an indigo system catd aspiration catheter (catd) was fractured at the hub upon removal from the packaging.The damage to the catd was found prior to use, and therefore the catd was not used in the procedure.The procedure was completed using a new catd.
Additional Manufacturer Narrative
Results: the catd was fractured approximately 1.0 cm from the hub.The distal tip of the catd was deformed.Conclusions: evaluation of the returned catd revealed a fracture just distal to the id band on the catheter¿s proximal end.This fracture was likely a result of mishandling during removal from the packaging tray.Further evaluation revealed the distal end of the catd was deformed.This damage was likely incidental and likely occurred during packaging for transit to penumbra.Penumbra catheters are 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 CATD ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7197791
• Report Number: 3005168196-2018-00145
• Device Sequence Number: 1812567
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 12/20/2017

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: 05/22/2020
• Device Catalogue Number: CATD
• Device Lot Number: F77277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1