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

Catalog Number CAT5

Device Problems Collapse (1099); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

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.This report is associated with mfr report number: 3005168196-2017-02077.The hospital discarded the device.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system cat5 aspiration catheter (cat5) and an indigo system separator 5 (sep5).During the procedure, the hospital technician accidently crushed the distal tip of the cat5 upon insertion into the non-penumbra sheath and therefore, the cat5 was removed.A new cat5 was then inserted, and the physician continued the procedure using a sep5 within the cat5.While in use, the bulb of the sep5 became broken while in use inside the patient, however the bulb did not fully detach from the pusher wire.The physician therefore was able to remove the sep5 and the bulb by simply retracting the sep5.The procedure was then completed using the same cat5 and a new sep5.There was no report of an adverse effect to the patient.

• 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: 7042964
• MDR Text Key: 93171913
• Report Number: 3005168196-2017-02078
• 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: 10/31/2017

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: Health Professional
• 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: 10/31/2017
• Initial Date FDA Received: 11/17/2017
• 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
• Patient Age: 58 YR
• Patient Weight: 82