MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problems Device Slipped (1584); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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

The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, the cat6 inadvertently fell off the sterile field and onto the floor.Therefore, the physician did not continue to use the cat6 and completed the procedure using a new cat6.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Describe event or problem for additional information provided by a penumbra sales representative on 07/20/2017.

Event Description

Additional information provided on 07/20/2017: during the procedure, after making successful passes with the cat6, the physician removed the cat6 to flush it.While the cat6 was being handed off to be used again, it was accidentally dropped onto the floor.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 6709259
• MDR Text Key: 80076169
• Report Number: 3005168196-2017-01142
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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: 12/07/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F73043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2016
• 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
• Patient Age: 4 YR
• Patient Weight: 5