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

Model Number	5MAXJET7-B
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
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 guidewire.It was noted that the patient anatomy was tortuous.During the procedure, the physician advanced the jet7 over a guidewire through the neuron max into the target vessel and completed one pass.While advancing the jet7 for the second pass, the physician experienced resistance; therefore, the jet7 was removed.Afterwards, the jet7 was flushed on the back table using a syringe and noticed that the distal tip of the jet7 expanded.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using a new jet7 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: 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 g.Box 3.Report source.Results: the jet7 had multiple kinks approximately 117.0 ¿ 124.0 cm from the hub.The device was stretched at approximately 131.0 cm from the hub.The total length of the returned jet7 was approximately 132.0 cm.Conclusions: evaluation of the returned jet7 revealed a stretch and kinks on its distal shaft.If the device is forcefully manipulated against resistance, damage such as this may occur.The reported tortuous anatomy may have contributed to resistance during the procedure.During functional testing, the jet7 was unable to be advanced through a demonstration neuron max due to the stretch on its distal shaft.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.

• 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: 10804676
• Report Number: 3005168196-2020-01921
• Device Sequence Number: 14402759
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 04/30/2023
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F97613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005