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

Catalog Number VEL160STR

Device Problems Material Frayed (1262); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the inner liner was stretched out of the lumen of the velocity.Conclusions: evaluation of the returned device revealed that the velocity inner liner was stretched.This type of damage likely occurred from the non-penumbra stent retriever being advanced through the velocity.If the non-penumbra stent retriever is advanced through the velocity and the stent frays the inner liner and subsequently, the liner becomes caught on the stent, damage such as this may occur.A stainless steel mandrel was advanced through the hub and out of the distal tip of the velocity without an issue.The non-penumbra stent retriever and the ace68 referred to in the complaint were not returned to penumbra for evaluation.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.

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a velocity delivery microcatheter (velocity).During the procedure, while using a velocity with a penumbra system ace 68 reperfusion catheter (ace68) and non-penumbra stent retriever device, it was noticed after the second pass that there was a ¿plastic¿ type of thread sticking out of the velocity and on the stent retriever device.Therefore, the procedure was completed using the same ace68, a new velocity and stent retriever device.It is unclear where the plastic material came from.Additionally, the physician did not mention resistance while advancing or retracting the stent retriever device from the velocity.There was no report of an adverse effect to the patient.

• 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: 7358572
• MDR Text Key: 103143544
• Report Number: 3005168196-2018-00625
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012629
• UDI-Public: 00814548012629
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: VEL160STR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 77 YR