MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

Catalog Number PSR3D

Device Problems Kinked (1339); Device Damaged Prior to Use (2284); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2017

Event Type  malfunction  

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 number: 3005168196-2018-00029.

Event Description

During preparation for a thrombectomy procedure, the physician was unable to track two penumbra system separators 3d (sep3ds) through a penumbra system 3max reperfusion catheter (3maxc) on the back table and subsequently, the sep3ds became kinked.The sep3ds became kinked prior to use and therefore, were not used in the procedure.The procedure was completed using a new sep3d and a velocity delivery microcatheter (velocity).

Manufacturer Narrative

Please note that although the device was initially reported as available for return, additional information provided indicated that the device was no longer available fore return; therefore, the report has been updated accordingly.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.This report is associated with mfr report numbers: 3005168196-2018-00029; 3005168196-2018-00434.The hospital disposed of the device.

Manufacturer Narrative

(b)(4).This report is associated with mfr report numbers: 3005168196-2018-00029 and 3005168196-2018-00434.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7164481
• MDR Text Key: 96388812
• Report Number: 3005168196-2018-00028
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• PMA/PMN Number: K162901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PSR3D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1