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

Model Number VEL160STR-A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

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 velocity snapped at the proximal end.The procedure was completed using a new velocity.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), neuron max 6f 088 long sheath 088 long sheath (neuron max), penumbra system ace 68 reperfusion catheter (ace68), non-penumbra stent retriever and guidewire.During the procedure, the physician advanced the ace68, velocity and guidewire into the neuron max to the target location.Aspiration started, and the solitaire was deployed.Then, as the physician started to remove the velocity, the velocity snapped at the proximal end.The procedure was completed with two additional passes using a new velocity, the same neuron max and the same ace68.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/13/2020: section b.Box 5.Describe event or problem.Results: the returned velocity was fractured at approximately 2.0 cm from the hub.Conclusions: evaluation of the returned velocity confirmed a fracture under the strain relief near the proximal end of the catheter.If the device is forcefully manipulated at extreme angles during use, damage such as a kink may occur.If the kinked device is further manipulated, the kink may worsen to a fracture.No other devices associated with the complaint was returned for evaluation.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.

• Brand Name: VELOCITY DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9535969
• MDR Text Key: 177214455
• Report Number: 3005168196-2019-02431
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (y/n): Y
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/06/2019

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: 05/27/2022
• Device Model Number: VEL160STR-A
• Device Catalogue Number: VEL160STR
• Device Lot Number: F90562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• 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: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1