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

Model Number 5MAXJET7KIT-B

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the jet7 was fractured approximately 1.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed a fracture underneath the strain relief.If the jet7 is forcefully manipulated at extreme angles during use, damage such this may occur.During functional testing, the jet7 was flushed with air while submerged in the bleach solution, and bubbles were observed coming from the fractured location underneath the strain relief.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.This report is associated with mfr report numbers: 3005168196-2020-02006, 3005168196-2020-02008.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).It was noted that the patient's anatomy was tortuous.During the procedure, the physician noticed the jet7 was leaking just beyond the hub while in use in the patient.Therefore, the jet7 was removed.Another jet7 was used to continue the procedure; however, the same issue occurred.It was also reported that while the neuron max was still inside the patient, the physician noticed that it was kinked; the neuron max was also removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and another neuron max.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.1.Section b.Box 5.Describe event or problem this report is associated with mfr report numbers: 1.3005168196-2020-02006 2.3005168196-2020-02008 h3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using penumbra system jet 7 reperfusion catheters (jet7)s and a neuron max 6f 088 long sheath (neuron max).It was noted that the patient''s anatomy was tortuous.During the procedure, the physician noticed the jet7 was leaking just beyond the hub on the back table.Therefore, the jet7 was not used in the procedure.Another jet7 was used to continue the procedure; however, the same issue occurred.It was also reported that while the neuron max was still inside the patient, the physician noticed that it was kinked; the neuron max was also removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and another neuron max.There was no report of an adverse effect to the patient.

• 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: 10847225
• MDR Text Key: 217137292
• Report Number: 3005168196-2020-02007
• 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: 01/01/2005,10/18/2020

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: 01/21/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• 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: 10/18/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1