MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Catalog Number 5MAXJET7KIT

Device Problems Failure to Advance (2524); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7).During the procedure, while attempting to advance the jet7 through a neuron max 6f 088 long sheath (neuron max), the physician experienced resistance and the jet7 became stuck and would not advance any further.Therefore, the jet7 was removed and found to be damaged.The procedure was completed using a new penumbra system ace 68 reperfusion catheter (ace68) and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the jet7 was fractured approximately 39.0, 73.0 and 73.5 cm from the hub.The device was kinked approximately 72.0 and 79.5 cm from the hub.The device was ovalized from approximately 81.0 ¿ 94.0 cm from the hub.The coil winds within the distal fractured segment of the jet7 was pulled out of the catheter lumen.Conclusions: evaluation of the returned jet7 confirmed a fracture and revealed the proximal fractured segment was within an rhv.If the rhv is overtightened onto the jet7, resistance may be experienced during retraction of the jet7 from the rhv.If the jet7 is forcefully retracted against resistance, damage such as a fracture may occur.Further evaluation revealed additional fractures, kinks and an ovalization.These damages were likely incidental to the reported complaint.The neuron max identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance experienced during the procedure could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-01510 1.Section h.Box6.Method code 2 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8857725
• MDR Text Key: 153294286
• Report Number: 3005168196-2019-01510
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (y/n): Y
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5MAXJET7KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• 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: 60 YR