MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM PUMP MAX CANISTER; DXE

Catalog Number IAPS2

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2017-02192.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure for an in-stent restenosis in the superficial femoral artery (sfa) using an indigo system separator 6 (sep6) and an indigo pump max canister (canister).During the procedure, while using the sep6 with an indigo system aspiration catheter 6 (cat6), the physician noticed that the indigo system was not aspirating properly.Upon checking the system, the hospital staff noticed that the canister had a crack in the side.Therefore, the canister was replaced with a new one and aspiration worked without issues.Later in the procedure, the scrub technologist inadvertently knocked the sep6 onto the floor.Therefore, the procedure was completed using a new sep6.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM PUMP MAX CANISTER
• 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: 7106905
• MDR Text Key: 94822825
• Report Number: 3005168196-2017-02193
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• 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
• Report Date: 11/14/2017

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 Catalogue Number: IAPS2
• Device Lot Number: F79834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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: 62 YR