MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problems Collapse (1099); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 product box was creased in two locations.The returned cat6 had a kink approximately 123.0 cm from the hub.The device also had ovalizations approximately 124.0 cm, 131.0 cm and 134.0 cm from the hub.Conclusions: evaluation of the returned cat6 revealed the distal tip was damaged.If the product was mishandled during preparation, damage such as this may occur.Further evaluation revealed the product box was also damaged.If the device was stored or handled poorly, this device may also have become damaged within the packaging.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.

Event Description

During preparation for a medical procedure, the hospital staff noticed that the tip of an indigo system aspiration catheter 6 (cat6) was crushed upon opening the package.The damage to the cat6 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new cat6.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 8044724
• MDR Text Key: 127345335
• Report Number: 3005168196-2018-02204
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): Y
• 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: 01/01/2005,10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: CAT6
• Device Lot Number: F84827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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