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 02/29/2020

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 basilar artery using an aspiration tubing (tubing), penumbra system 4max reperfusion catheter (4maxc), and penumbra system aspiration pump max 110 (pump max).During the procedure, the physician connected the 4maxc to the pump max using the tubing.However, the vacuum pressure from the pump max was not reaching the desired -28 inhg despite confirming there were no loose connections; therefore, the tubing was removed.The procedure was completed using another tubing and the same 4maxc and pump max.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: 9892265
• MDR Text Key: 187956997
• Report Number: 3005168196-2020-00459
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K160449
• 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: 01/01/2005,03/05/2020

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: 03/06/2020
• Device Catalogue Number: SCW
• Device Lot Number: F74809
• 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: 03/05/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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