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

Model Number VEL160STR-A

Device Problem Break (1069)

Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160)

Event Date 08/25/2020

Event Type  Injury  

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 numbers: 3005168196-2020-01508, 3005168196-2020-01509.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the left middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), penumbra system jet 7 reperfusion catheter (jet7), penumbra system ace 68 reperfusion catheter (ace68), neuron max 6f 088 long sheath (neuron max), neuron select catheter 6f (6f select), and a non-penumbra sheath (8f).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician used an 8fr sheath for femoral access and then advanced a neuron max and a 6f select to access the left common carotid artery.Next, a guidewire and velocity were used to access the left internal carotid artery.It was reported that the patient was moving significantly during the procedure.The physician made multiple passes under manual syringe aspiration with an ace68 and with a jet7.After a manual aspiration attempt through the jet7, the physician re-inserted the velocity into the jet7 and noticed the velocity would not advance out the distal tip of the jet7.Subsequently, the physician noticed the distal portion of the velocity had broken off upon previously removing it out from the jet7 and remained in the m1.The physician then used a snare device and stent retriever (solitaire) to remove the distal portion of the velocity.It was also reported that the patient continued to move significantly during removal of the distal portion of the velocity.The physician attempted to intubate the patient which induced vomiting.It was reported that both ace68 and jet7 became kinked during the multiple passes due to the patient¿s movements and tortuous anatomy.The procedure was completed using a new velocity and the same neuron max.Post procedure, fluoroscopic images revealed no extravasation.The following day, a computed tomography (ct) scan revealed evidence of vessel injury and bleeding.The relationship between the vessel injury and bleeding to the velocity is unknown.

Manufacturer Narrative

Please note that the device associated with this report was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: 1.Section d.Box 10.Device available for evaluation? (do not send to fda).2.Section h.Box 3.Reason for non-evaluation.3.Section h.Box 3.''other'' reason for non-evaluation.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: 1.3005168196-2020-01508, 2.3005168196-2020-01509.

• Brand Name: VELOCITY DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10552506
• MDR Text Key: 207510805
• Report Number: 3005168196-2020-01507
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: VEL160STR-A
• Device Catalogue Number: VEL160STR
• Device Lot Number: F97294
• 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: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR