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

Catalog Number	IAPS2
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7106905
• Report Number: 3005168196-2017-02193
• Device Sequence Number: 1933368
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Catalogue Number: IAPS2
• Device Lot Number: F79834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR