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

Catalog Number CAT5

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2018

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.The hospital disposed of the device.

Event Description

During preparation for a medical procedure, the hospital staff inadvertently kinked the indigo system cat5 aspiration catheter (cat5) on the back table while taking it out of the hoop.The damage to the cat5 occurred prior to use.Therefore, the cat5 was not used in the procedure.The procedure was completed using a new cat5.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• 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: 7360119
• MDR Text Key: 103171894
• Report Number: 3005168196-2018-00629
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (y/n): N
• 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: 03/02/2018

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: Physician
• Device Expiration Date: 03/12/2020
• Device Catalogue Number: CAT5
• Device Lot Number: F74957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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