MAUDE Adverse Event Report: PENUMBRA, INC. VELOCITY DELIVERY MICROCATHETER; DQY

Catalog Number VEL160STR

Device Problems Kinked (1339); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a velocity delivery microcatheter (velocity).During the procedure, the physician was unable to advance a guidewire through the velocity after advancing the velocity into the patient using a non-penumbra catheter.The velocity was therefore removed.Upon removal, the physician noticed that the velocity was kinked.The procedure was completed using a new velocity and the same catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the velocity was fractured approximately 67.0 cm from the hub.The velocity also had a slight bend on the strain relief near the hub.A non-penumbra guidewire was found fractured within the velocity.The velocity was damaged and, therefore, was not able to be functionally tested.Conclusions: evaluation of the returned velocity revealed a fractured device.The velocity was reportedly advanced into the non-penumbra catheter without a guidewire.If the catheter is already placed in anatomy and a guide wire is attempted to be advanced through the catheter, resistance may be experienced.If the guidewire is forcefully manipulated against this resistance, the guidewire will likely damage the catheter and damage such as a kink may occur.Further evaluation revealed that the device was fractured and bent.This damage was not mentioned in the reported complaint, therefore the fracture and bend are likely incidental and may have occurred during removal from the patient or during packaging for return to penumbra.Penumbra catheters are visually 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.

• Brand Name: VELOCITY DELIVERY MICROCATHETER
• Type of Device: DQY
• 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: 7491149
• MDR Text Key: 107495042
• Report Number: 3005168196-2018-00932
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100826
• 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,Followup
• Report Date: 01/01/2005,04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2021
• Device Catalogue Number: VEL160STR
• Device Lot Number: F81814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• 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: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1