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

Model Number	5MAXJET7KIT-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra 8f sheath, and a non-penumbra guidewire.During the procedure, while advancing the jet7 over the guidewire through the 8f sheath, the physician experienced resistance and subsequently noticed that blood was leaking out.It was reported that the jet7 broke and braided material was exposed; therefore, the jet7 was removed.The procedure was completed using another catheter and the same sheath.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Results: the returned jet7 was fractured at approximately 40.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a fracture.If the device is forcefully advanced against resistance, damage such as a kink may occur.If the kinked device is further manipulated, the kink may worsen to a fracture.The non-penumbra 8f sheath was not returned for evaluation; therefore, the cause of the reported resistance was unable to be determined.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.

• 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: 9406515
• Report Number: 3005168196-2019-02218
• Device Sequence Number: 1712027
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019
• 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: 03/27/2022
• Device Model Number: 5MAXJET7KIT-A
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F89296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005