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

Catalog Number	IAPS2
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-00280, 3005168196-2019-00282, 3005168196-2019-00283.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system cat rx kit and a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician was unable to aspirate the clot using an indigo system catrx aspiration catheter (catrx) and was unable to get suction through the catrx with the pump max.Therefore, both the catrx and pump max were removed.The procedure was completed using balloon angioplasty.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the canister.Conclusions: evaluation of the returned devices revealed that the catrx lumen was blocked with coagulated blood.If the catrx lumen is not cleared during use, blood may enter the lumen and begin to coagulate.If the lumen of the catrx is occluded from coagulated blood, aspiration may be affected.During functional testing the coagulated blood was removed from the catrx lumen.The catrx, aspiration tubing, canister, and the pump max were all connected as an aspiration system.The pump max was powered on and the catrx was able to aspirate without an issue.Penumbra catheters and aspiration tubing are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra pumps and canisters are visually inspected and functionally tested during incoming inspection by quality.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 numbers: 1.3005168196-2019-00280, 2.3005168196-2019-00282, 3.3005168196-2019-00283.

• Brand Name: INDIGO PUMP MAX CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8339156
• Report Number: 3005168196-2019-00281
• Device Sequence Number: 13504393
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Catalogue Number: IAPS2
• Device Lot Number: F87039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005