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

Model Number	5MAXJET7-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number:100870000-2020-8074 results: the jet7 was fractured approximately 109.0 cm from the hub and was slightly stretched on both sides of the fracture.The device was kinked approximately 1.0 and 123.0 cm from the hub.The total length of the jet7 was approximately 133.5 cm.Conclusions: evaluation of the returned jet7 confirmed a distal shaft fracture.Further evaluation revealed signs of stretching on both sides of the fracture.This indicates that the device was likely retracted against resistance prior to fracturing.The root cause of the resistance could not be determined.Further evaluation also revealed a kink near the hub and on the distal shaft.This damage was likely incidental to the reported complaint.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra sheath, non-penumbra microcatheter, and non-penumbra stent retriever.During the procedure, the physician made one pass using the jet7, microcatheter, and stent retriever.The jet7 and stent retriever was then removed, and the jet7 was flushed.Next, a second pass was made using the same jet7, microcatheter and a new stent retriever.Subsequently, while removing the jet7, the physician noticed the jet7 to be broken approximately 10 centimeters from the distal end.The physician ended the procedure at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10825975
• Report Number: 3005168196-2020-01923
• Device Sequence Number: 14286413
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F99150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005