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

Catalog Number CAT8STR85

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 thrombectomy procedure, an indigo system aspiration catheter 8 (cat8) became kinked upon removal from the packaging.The damage to the cat8 occurred prior to use and, therefore, it was 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: 8771191
• MDR Text Key: 150413574
• Report Number: 3005168196-2019-01323
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016269
• UDI-Public: 00814548016269
• 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: 01/01/2005,06/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Catalogue Number: CAT8STR85
• Device Lot Number: F84288
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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