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

Model Number	5MAXJET7KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
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 in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a penumbra system 3max reperfusion catheter (3maxc) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician advanced the neuron max into the patient, then used the 3maxc to bring up the jet7 to the treatment site through the neuron max.The physician then completed one pass using the jet7.While removing the jet7 from the crosscut valve of the neuron max after completion of the pass, the jet7 fractured at the distal end.The procedure was completed using other devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the follow-up #1 mfr report was inadvertently submitted blank.Results: the jet7 was fractured approximately 7.0 cm from the hub.No visible damage to the distal end of the jet7.Conclusions: evaluation of the returned jet7 confirmed that the catheter was fractured on the proximal end.If the jet7 is forcefully retracted against resistance, damage such as a fracture may occur.Further evaluation of the returned jet7 revealed a 3maxc inside the jet7, and a non-penumbra device inside the 3maxc.These devices were not removed from the fractured jet7, in order to prevent damages that did not contribute to the reported complaint.In addition, there was no damage to the distal shaft of the returned jet7, and therefore, the reported jet7 fracture at the distal end could not be confirmed.Evaluation the returned 3maxc revealed that the catheter was fractured inside the jet7.This damage likely occurred due to the jet7 fracture during the procedure.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.This report is associated with mfr report number: 3005168196-2020-01480.
Additional Manufacturer Narrative
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• 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: 10053510
• Report Number: 3005168196-2020-00642
• Device Sequence Number: 14138966
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K173761
• 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,Followup
• Report Date (Section B): 04/24/2020
• 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: 09/22/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 08/20/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/01/2020; 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Date Report Sent to FDA: 01/01/2005