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 08/03/2020

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 middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and non-penumbra sheath.During the procedure, the physician advanced the jet7 into the target vessel and aspirated the clot into the jet7.Next, while retracting the jet7 containing the clot, the physician experienced resistance and the distal half of the jet7 became stretched.Subsequently, the physician pulled the jet7 and successfully removed the clot.The procedure was completed using a new jet7 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that two penumbra system jet 7 reperfusion catheters (jet7) were returned for evaluation: 1) the subject jet7, and 2) the jet7 used to complete the procedure; however, it is unknown which of the two returned jet7s corresponds to the subject jet7 lot number.The investigation results and conclusions for both returned jet7s are included in this report.Results: the first returned jet7 was stretched approximately 117.0 thru 135.0 cm from the hub.The total length of the returned jet7 was approximately 138.0 cm.The second returned jet7 was stretched approximately 120.0 thru 129.0 cm and 131.5 thru 132.5 cm from the hub.The total length of the returned jet was approximately 135.0 cm.Conclusions: evaluation of the first returned jet7 confirmed that the catheter was stretched.If the catheter is forcefully retracted against resistance damage such as stretching may occur.During the functional test, resistance was encountered while attempting to advance a demonstration velocity through the stretched distal shaft of the returned jet7, and the velocity could not be advanced any further.Resistance was encountered while attempting to advance the stretched distal shaft of the returned jet7 through the hub of the demonstration neuron max, and the jet7 could not be advanced any further.Evaluation of the second returned jet7 confirmed that the catheter was stretched.If the catheter is forcefully retracted against resistance damage such as stretching may occur.During the functional test, resistance was encountered while attempting to advance a demonstration velocity through the jet7 and the velocity could not be advanced any further due to the stretching on the distal shaft.Resistance was also encountered while attempting to advance the returned jet7 stretched distal shaft through an rhv attached to the demonstration neuron max, and the jet7 could not be advanced any further.The root cause of resistance during the procedure 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: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10468694
• MDR Text Key: 205491381
• Report Number: 3005168196-2020-01334
• 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: 01/01/2005,08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• 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: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1