MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE CANISTER; DXE

Catalog Number	IAPS3
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the canister had blood within the device but was undamaged.Conclusions: evaluation of the returned catrx revealed a kinked and ovalized device that was unable to be flushed due to coagulated blood.The reported complaint mentioned that aspiration stopped after making a first pass.The kinks and ovalizations were not reported in the complaint; therefore, these damages were likely incidental to the complaint and may have occurred after the procedure.However, if the kinks and ovalizations were present prior to the first pass, this could contribute to the reported inability to continue aspirating.Evaluation of the returned canister revealed a fully functional device.During functional testing, the canister was inserted onto a demonstration engine and was able to generate vacuum pressure within specification.Evaluation of the returned tubing revealed no device issues.During functional testing, fluid was able to be aspirated through the tubing without issue.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra canisters and tubing are visually inspected and functionally tested during incoming quality inspection.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: 3005168196-2019-00699; 3005168196-2019-00701.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx) and indigo system aspiration tubing (tubing) from an indigo system catrx kit, and a penumbra engine canister (canister).During the procedure, the physician made one pass using the catrx and reported that the aspiration had stopped working.He decided to remove the catrx and tubing from use in the patient and confirmed that there was no aspiration using the system.Subsequently, the physician removed the catrx, tubing, and canister, and completed the procedure using a new catrx, new tubing, and a new canister.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA ENGINE CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8511254
• Report Number: 3005168196-2019-00700
• Device Sequence Number: 13895066
• Product Code: DXE
• UDI-Device Identifier: 00814548019703
• UDI-Public: 00814548019703
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180412
• 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
• Report Date (Section B): 03/16/2019
• 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: IAPS3
• Device Lot Number: S10229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2019
• Initial Report FDA Received Date: 04/12/2019
• 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
• Date Report Sent to FDA: 01/01/2005