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

Catalog Number CAT8XTORQ115

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

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the returned cat8 had a kink approximately 31.0 cm from the hub and ovalization approximately 60.0 cm from the hub.Conclusions: evaluation of the returned cat8 revealed two kinks along the length of the catheter shaft.These damages were likely a result of forcefully retracting the cat8 from its packaging at extreme angles.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 an indigo system aspiration catheter 8 (cat8) had two major kinks before removal from its packaging hoop.The damage to the cat8 was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new cat8.There was no report of adverse effect to the patient.

• 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: 8069383
• MDR Text Key: 127342176
• Report Number: 3005168196-2018-02255
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F82567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• 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: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• 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