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

Catalog Number CAT8TORQ85

Device Problems Shipping Damage or Problem (1570); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Both indigo system aspiration catheter 8 (cat8¿s) devices were ovalized approximately 26.0 cm from the hub.Evaluation of the returned devices revealed that both cat8 devices were ovalized.This type of damage likely occurred due to improper storage of the devices.The display cardboard boxes and shipping box were not returned for evaluation.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: 3005168196-2017-00723.

Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed a crease around the mid/distal shaft of two indigo system aspiration catheter 8 (cat8¿s) devices upon opening the device packaging box.Upon further examination, it was observed that the box of the devices was bent right where the crease in the cat8's were observed.The damaged cat8 devices were found prior to use and therefore, were not used in the procedure.The procedure was completed using a new cat8.

• 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: 6559016
• MDR Text Key: 74915869
• Report Number: 3005168196-2017-00724
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F72551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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