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

Catalog Number CAT6

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Results: dried blood was found on the exterior of the returned indigo system aspiration catheter 6 (cat6) and inside the hub.The cat6 was kinked approximately 1.0 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed that the cat6 was damaged on its proximal end.If the device is forcefully manipulated at extreme angles during removal from the hoop, the device may become kinked.During functional testing, air leaked from the kink near the hub when flushed through the catheter.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 thrombectomy procedure, the hospital technician flushed the indigo system aspiration catheter 6 (cat6) and fluid was noticed to be leaking near the hub of the cat6.Upon inspection, a crack in the catheter was found.The damage to the cat6 was found prior to use.Therefore, the cat6 was not used in the procedure.The procedure was completed using a new cat6.

• Brand Name: INDIGO SYSTEM CAT 6 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: 8035246
• MDR Text Key: 126074061
• Report Number: 3005168196-2018-02178
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/04/2018

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: Health Professional
• Device Expiration Date: 07/09/2021
• Device Catalogue Number: CAT6
• Device Lot Number: F84547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• 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
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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