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

Catalog Number	CATD
Medical Device Problem Codes	Collapse (1099); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the second catd was ovalized approximately 51.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that both returned catds were ovalized.This type of damage typically occurs due to damage in transit.If the device slips between the top and bottom packaging tray, and the packaging is forcefully gripped, damage such as this may occur.A mandrel was attempted to be advanced through both catds.However, resistance was encountered as the mandrel met the ovalization in the distal tip of the catheters and the mandrel advanced out of the distal tip with some resistance.Penumbra catheters are visually 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.This report is associated with mfr report number: 3005168196-2018-00618.
Event or Problem Description
During preparation for a medical procedure, the hospital staff found that the tips of two indigo system catd aspiration catheters (catds) were crushed upon removal from the packaging.The damages to the catds were found prior to use.Therefore, the catds were not used in the procedure.The procedure completed using a thrombectomy device.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7355972
• Report Number: 3005168196-2018-00619
• Device Sequence Number: 2023369
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 02/26/2018

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: 05/22/2020
• Device Catalogue Number: CATD
• Device Lot Number: F77277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1