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

Catalog Number CAT8XTORQ115

Device Problems Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2018

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, the hospital staff found that the indigo system aspiration catheter 8 (cat8) had been crushed at the middle of the catheter, before removal from the packaging.The damage to the cat8 was found prior to use and therefore it was not used in the procedure.The procedure was completed using another cat8.

Manufacturer Narrative

Results: the cat8 was ovalized from approximately 48.0 ¿ 49.0 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed an ovalized device.The reported complaint mentioned that the damage occurred before removal of the device from its packaging.This damage was likely a result of improper handling during transit or during storage of the device.The root cause of the reported complaint could not be determined.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: 8241909
• MDR Text Key: 132916614
• Report Number: 3005168196-2019-00076
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• 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: 01/01/2005,12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F85199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• 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: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1