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

Model Number 5MAXJET7KIT-B

Device Problems Suction Problem (2170); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), guidewire, and non-penumbra microcatheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician placed the jet7, guidewire, and microcatheter in the target vessel and aspirated using the jet7.As the aspiration stopped, the physician removed the jet7.Upon removal, the jet7 was found ovalized four to five centimeters from the distal end; therefore, the jet7 was not used for the remainder of the procedure.It was also reported that without aspiration pressure, the jet7 reverted to its original form.The procedure was completed using another jet7 and the same guidewire and microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the jet7 was kinked approximately 29.5 cm from the hub.The jet7 was stretched approximately 127.0-132.5 cm from the hub.Stretch marks were present approximately 122.0-123.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed that the distal shaft was stretched.If the jet7 is forcefully retracted during use, damage such as stretching may occur.During functional testing, the jet7 was connected to demonstration pump and able to aspirate fluid without an issue.There was some deformation noted under aspiration due to stretch damage.No other devices associated with the complaint were 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 JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10098707
• MDR Text Key: 192661857
• Report Number: 3005168196-2020-00683
• 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: 01/01/2005,05/07/2020

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: 09/26/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• 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: 05/07/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1