MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

Catalog Number CAT5

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a thrombectomy procedure, the physician found that an indigo system cat5 aspiration catheter (cat5) was broken into two pieces upon removal from the packaging.The damage to the cat5 was found prior to use.Therefore, the cat5 was not used in the procedure.The procedure was completed using a new cat5.

Manufacturer Narrative

Results: the indigo system cat5 aspiration catheter (cat5) was fractured approximately 77.0 cm from the hub.The device was ovalized approximately 127.5 cm from the hub.Conclusions: evaluation of the returned cat5 confirmed a fracture.If the device is forcefully manipulated at extreme angles during removal from its packaging hoop, damage such as a fracture may occur.Further evaluation revealed a distal ovalization.This damage was likely incidental to the reported complaint.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 CAT5 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8716722
• MDR Text Key: 148992462
• Report Number: 3005168196-2019-01199
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/22/2019

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: 08/30/2021
• Device Catalogue Number: CAT5
• Device Lot Number: F85602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• 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: 05/22/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1