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

Model Number 5MAXJET7-B

Device Problems Break (1069); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.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) and middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), penumbra engine (engine), penumbra engine canister (canister), and aspiration tubing (tubing).During the procedure, the physician connected the jet7 to the engine via the tubing and placed the canister in the engine.It was reported that the tubing and canister had already been checked.While aspirating the jet7 with the engine in the target vessel on the first pass, none of the four indicator lights on the engine were illuminated, and full aspiration was not achieved; therefore, the physician decided to remove the jet7.Upon removal, the distal tip of the jet7 was observed to be broken.The procedure was completed using another jet7 and the same engine, canister, and tubing, along with a penumbra system 3d revascularization device (psr3d).A thrombolysis in cerebral infarction (tici) grade 3 recanalization was achieved.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-00608.Results: the jet7 was stretched approximately 128.0-130.0 cm from the hub.The jet7 was ovalized approximately 112.0 cm from the hub.The distal tip of the jet7 was ovalized.During functional testing, the jet7 was connected to a demonstration aspiration tubing, demonstration pump, and canister.The jet7 was able to aspirate fluid into the canister without an issue.Air was injected into the catheter while submerged, and no leaks were identified in the catheter.Conclusions: evaluation of the returned jet7 was unable to confirm the reported event.Evaluation revealed that the distal tip was stretched and ovalized.If the device is forcefully retracted against resistance, damage such as stretching may occur.If the device is inadvertently gripped or pinched during handling, ovalizations may occur.The returned jet7 was able to aspirate water without tissue when connected to a demonstration pump.Further evaluation of the returned jet7 revealed an ovalization along the catheter shaft.This damage was likely incidental to the reported event.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: 10017761
• MDR Text Key: 189615242
• Report Number: 3005168196-2020-00608
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• 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: 01/01/2005,04/08/2020

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: 12/04/2022
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F94643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• 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: 04/08/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1