MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Catalog Number 5MAXJET7KIT

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

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 right internal carotid artery (ica) using a penumbra system jet 7 kit.During the procedure, the physician made the first pass using a penumbra system jet 7 reperfusion catheter (jet7) and other non-penumbra devices.The physician then performed an angiogram and visualized reperfusion in some areas of the brain; however, clot had traveled to the m2 segment.The physician proceeded to make another pass in the m2 segment using the same devices.Subsequently, the devices were removed from the patient and placed on the back table.The physician then noticed that the distal part of the jet7 was accordioned.It was also reported that upon flushing the jet7, the jet7 began to expand proximal to the noted damage.A new jet7 was used; however, the physician decided to end the procedure.

Event Description

The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system jet 7 kit.During the procedure, the physician made the first pass using a penumbra system jet 7 reperfusion catheter (jet7) and other non-penumbra devices.The physician performed an angiogram and visualized reperfusion in the distal m1.Additionally, a clot was identified in the m2 segment.The physician proceeded to make a pass in the m2 segment using the same devices.Subsequently, the devices were removed from the patient and placed on the back table.The physician then noticed that the distal part of the jet7 was accordioned.It was also reported that upon flushing the jet7, the jet7 began to expand proximal to the noted damage.A new jet7 was used; however, the physician decided to end the procedure.Additional information received indicated that the patient was placed on aspirin post procedure and had a bleed post thrombectomy.The patient was discharged post a month.

Manufacturer Narrative

Please note that the following was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.Adverse event and/or product problem.Outcomes attributed to adverse event.Type of reportable event.Changed device code from 2993 to 2976.Device code 2.Patient code 1 results: the jet7 was kinked approximately 117.5, 122.0, and 125.0 thru 127.0 cm from the hub.The jet7 was stretched approximately 125.0 thru 127.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed that the catheter was stretched.This type of damage typically occurs due to retraction of the device against resistance.During functional testing, the returned jet7 was unable to advance into a demonstration neuron max due to the distal tip damage.This indicates that this damage may have occurred during removal from the patient.If the rhv is not fully opened upon retraction from the patient it may contribute to the damage observe on the returned device.Further evaluation of the returned jet7 revealed that the catheter was kinked.These kinks were proximal to the reported damaged; therefore, they were likely incidental to the reported event.No other devices identified in the complaint were not returned 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.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9182962
• MDR Text Key: 162365864
• Report Number: 3005168196-2019-01905
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F91955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• 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: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR