MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the jet7 had multiple kinks approximately 111.0 ¿ 123.0 cm from the hub.The device was stretched approximately 128.0 cm from the hub.The distal tip and marker band were ovalized approximately 131.5 cm from the hub.The total length was 131.5 cm.Conclusions: evaluation of the returned jet7 revealed a stretching near its distal tip.Further evaluation of the device revealed multiple kinks and an ovalization on its distal shaft.If the jet7 is manipulated against resistance during use, damage such as this may occur.During functional testing, the jet7 was unable to advance into a demonstration neuron max due to the distal ovalization.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 in the internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, prior to use, the hospital staff noticed that a jet7 was fractured near the hub after removal of the packaging.The damage to the jet7 was found prior to use and therefore, the jet7 was not used in the procedure.A new jet7 was opened and advanced over a guidewire through the neuron max into the ica.The jet7 was then connected to the pump and aspiration was initiated.A pass was completed using the jet7 and then the jet7 was removed.After the removal, it was noticed that three to four centimeters near the distal tip of the jet7 was deformed; therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10759849
• Report Number: 3005168196-2020-01849
• Device Sequence Number: 11578690
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K190010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2020
• 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: 03/17/2023
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F96999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• 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: 10/05/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005