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

Model Number VEL160STR-A

Device Problems Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2019

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 in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), velocity delivery microcatheter (velocity), and non-penumbra stent retriever.During the procedure, the physician completed one pass in the target vessel using the ace68, velocity, and stent retriever and complete reperfusion was not achieved.Next, while retracting the stent retriever and velocity through the ace68, the physician experienced resistance and heard a noise.Upon removal of the stent retriever and velocity, the proximal end of the velocity was noticed to be stretched.The procedure was completed using other devices.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following device code listed on the initial report was reported in error and should not have been reported: 1.4012 please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2019-02356.1.Section b.Box 5.Describe event or problem.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), velocity delivery microcatheter (velocity), and non-penumbra stent retriever.During the procedure, the physician completed one pass in the target vessel using the ace68, velocity, and stent retriever, but complete reperfusion was not achieved.It was reported that while retracting the stent retriever and velocity through the ace68 to complete the pass, the physician heard a sound.Upon removal, the proximal end of the velocity was noticed to be stretched.The procedure was completed using the same ace68 and other devices.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the velocity was kinked/fractured approximately 61.5 cm from the hub.Conclusions: evaluation of the velocity revealed that the catheter was kinked/fractured.If the velocity is retracted at an extreme angle, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fractured device.No other device associated with the complaint was returned for evaluation.Therefore, the root cause of resistance could not be determined.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
• MDR Report Key: 9491869
• MDR Text Key: 174938260
• Report Number: 3005168196-2019-02356
• 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,Followup
• Report Date: 01/01/2005,11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: VEL160STR-A
• Device Catalogue Number: VEL160STR
• Device Lot Number: F89202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR