MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION TUBING; NRY

Catalog Number SCW

Device Problem Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.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.

Event Description

The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using aspiration tubing (tubing), a penumbra system 3max reperfusion catheter (3maxc), a penumbra system 3max separator (3maxs), a penumbra engine (engine), and a penumbra engine canister (canister).During the procedure, the engine indicator lights were not illuminating.It was reported that the tubing flow switch was in the off position after connecting it to the engine.The physician reset the devices; however, the issue was unresolved.It was confirmed that the engine and canister were functioning properly; therefore, the physician decided to remove the tubing.The procedure was completed using new tubing, the same engine, the same canister, and the same 3maxc and 3maxs.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION TUBING
• Type of Device: NRY
• 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: 11069601
• MDR Text Key: 226020697
• Report Number: 3005168196-2020-02349
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,11/24/2020

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: 12/25/2021
• Device Catalogue Number: SCW
• Device Lot Number: C13114
• Was Device Available for Evaluation?: No
• 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: 11/24/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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