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

Catalog Number SCW

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

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 internal carotid artery (ica) using an aspiration tubing (tubing).During the procedure, the physician placed a non-penumbra balloon catheter in target vessel and performed continuous aspiration; however, there was low amount of aspirated blood, although the pump was functioning properly.The physician then checked the connector of the tubing and noticed air leaking from the connection.It was also reported that the physician attempted to tighten the connection; however, no improvement was made with the connection.Therefore, the tubing was removed.The procedure was completed using manual aspiration with a syringe.There was no report of an adverse effect to the patient.

• Brand Name: 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: 9117521
• MDR Text Key: 160013896
• Report Number: 3005168196-2019-01819
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K151623
• 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: 01/01/2005,08/29/2019

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: 08/09/2019
• Device Catalogue Number: SCW
• Device Lot Number: F71013
• 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: 08/29/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2016
• 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