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

Model Number 5MAXJET7KIT-B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2020

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 left internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7), penumbra system 3max reperfusion catheter (3maxc), and guide catheter.It was noted that the patient¿s anatomy was severely tortuous in the abdomen.During the procedure, the physician experienced resistance while advancing a guidewire, 3maxc, and jet7 through the balloon catheter.Therefore, the guidewire, 3maxc and, jet7 were removed.It was a reported that while flushing the jet7 on the back table, the jet7 expanded approximately 20mm from the distal tip.The physician then advanced a non-penumbra microcatheter through the guide catheter; however, resistance was encountered while advancing through the tortuous vessels.Therefore, the microcatheter and guide catheter were removed.It was also reported that the guide catheter was found to be kinked on the back table.The physician was unable to complete the procedure using other devices and decided to end the procedure at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the distal shaft of the jet7 was stretched approximately 129.5 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed that the distal shaft of the catheter expanded while being flushed.Further evaluation of the device revealed that the distal shaft was stretched.If the jet7 is forcefully manipulated against resistance, damage such as stretching may occur.During the functional test, a demonstration microcatheter could not be advanced through the returned jet7, and the returned jet7 could not be advanced through a demonstration neuron max due to the stretched distal shaft on the returned jet7.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.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: 10242660
• MDR Text Key: 197915948
• Report Number: 3005168196-2020-00896
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• 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: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR