MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Results: the returned 3maxc was fractured at approximately 58.0 cm from the hub.The device was ovalized at approximately 155.0 cm and 157.0 cm from the hub.Conclusions: evaluation of the returned 3maxc revealed a fractured device.The complaint reported that the 3maxc was kinked upon removal from its packaging.If the device is forcefully retracted from its packaging hoop at extreme angles, damage such as a kink may occur.If a kinked device is further manipulated, damage such as a fracture may occur.Further investigation revealed ovalizations on its distal shaft.Based on the reported complaint, the fracture and ovalizations were likely incidental to the reported complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

During preparation for a medical procedure, the hospital staff noticed that the penumbra system 3max reperfusion catheter (3maxc) was kinked upon removal from the packaging.The damage to the 3maxc was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new 3maxc.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• 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: 8604173
• MDR Text Key: 144844863
• Report Number: 3005168196-2019-00948
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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: 3MAXC
• Device Lot Number: F87664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• 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
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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