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

Catalog Number 5MAXJET7BKIT

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2024

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the m1 using a benchmark bmx96 access system (bmx96) and a penumbra system jet 7 reperfusion catheter (jet7), and sheath.During the procedure, the physician completed four passes.While retracting the jet7 after the last pass, the physician experienced resistance.Then the physician decided to remove jet7 and bmx96 together.During removal, the jet7 was found to be fractured and the distal portion was left in the right femoral artery.Access was regained in the left femoral and a snare was used to remove the distal length of the jet7.The procedure was completed at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned jet7 confirmed a fracture.Further evaluation revealed that the distal fractured segment was stretched.If the device is retracted against resistance, damage such as stretching, and a subsequent fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation of the returned jet7 also revealed kinks throughout the length of both fractured segments.This damage was likely incidental to the complaint and may have occurred during removal from the patient or packaging for return to penumbra.Penumbra catheters are 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.H3 other text : placeholder.

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: section h.Box 6.Patient code 1 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18647700
• MDR Text Key: 334612399
• Report Number: 3005168196-2024-00041
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: F103849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• 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: 01/10/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female