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

Catalog Number CAT8TORQ85

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

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a medical procedure, an indigo system aspiration catheter 8 (cat8) was found to be ovalized at the distal end upon removal from the packaging.The cat8 was therefore not used in the procedure.The procedure was completed using another cat8.

Manufacturer Narrative

Results: the returned device was ovalized from approximately 2.0 cm to 4.0 cm from the hub.Conclusions: evaluation of the returned cat8 revealed a device with an ovalization on the proximal end.If the device is forcefully gripped or pinched during removal from its packaging, damage such as this may occur.No damage was present on the distal end of the device.The damage in the reported complaint was likely the ovalization found on the proximal end of the device.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 ASPIRATION CATHETER 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8382275
• MDR Text Key: 137800290
• Report Number: 3005168196-2019-00395
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F83744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• 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: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1