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

Model Number	5MAXJET7-B
Medical Device Problem Codes	Break (1069); 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	10/03/2020
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), non-penumbra microcatheter, balloon guide catheter, and sheath.During the procedure, the physician accessed the target vessel via the radial artery using the balloon guide catheter and sheath, followed by performing manual aspiration using a syringe and the jet7.While retracting the jet7 from the balloon guide catheter on the first pass, the physician experienced slight resistance, and the distal end of the jet7 fractured.Upon removal of the jet7, the physician noticed that the tip of the jet7 was still inside the balloon guide catheter.Therefore, the balloon guide catheter containing the jet7 was removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), non-penumbra sheath, and the same microcatheter.It was reported that the physician re-accessed the target vessel via the femoral artery.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 was stretched approximately 105.0 thru 120.5 cm from the hub.The jet7 was fractured approximately 120.5 cm from the hub.The marker band was present on the distal tip of distal fractured segment.Conclusions: evaluation of the returned jet7 confirmed that the catheter was fractured and revealed stretching on the catheter shaft.If the jet7 if forcefully retracted against resistance, damage such as stretching, and a subsequent fracture may occur.Evaluation of the returned non-penumbra balloon guide catheter revealed a kink.The root cause of this damage could not be determined, however, this kink likely contributed to the reported resistance prior to the jet7 stretching and fracturing during the procedure.During the functional test, resistance was encountered due to the kink in the catheter while attempting to advance a demonstration jet7 through the non-penumbra device, and the jet7 could not be advanced any further.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.

• 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: 10759785
• Report Number: 3005168196-2020-01848
• Device Sequence Number: 3261725
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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,Followup
• 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: 03/12/2023
• Device Model Number: 5MAXJET7-B
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F96920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005