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

Model Number 5MAXJET7KIT-B

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

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 using a penumbra system jet 7 reperfusion catheter (jet7) and penumbra engine (engine).During the procedure, while advancing the jet7 to make a pass, the physician noticed a leak in the proximal end of the jet7 towards the hub.It was reported that due to the damage to the jet7, only two lights would illuminate on the engine.However, the physician continued to use the same jet7 and engine to complete the procedure.It was also reported that the physician noticed the leak to the proximal end while removing the jet7 out from the patient.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the jet7 was kinked approximately 1.5 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a leak from underneath the strain relief.During the functional test, the jet7 was flushed while submerged, and bubbles were observed coming from underneath the strain relief.The strain relief was unraveled, and a hole was observed in the proximal shaft.If the jet7 is manipulated at an extreme angle during use, damage such as a kink may occur.Subsequently, if the kinked jet7 is further manipulated, the kink may worsen to a fracture.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: 9759836
• MDR Text Key: 188393116
• Report Number: 3005168196-2020-00248
• 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: 01/01/2005,02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1