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

Catalog Number	5MAXJET7KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
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 middle cerebral artery (mca) using a penumbra system jet7 kit (kit).During the procedure, after making an initial pass with the penumbra system jet7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max), the physician noticed that the jet7 was not able to achieve proper aspiration.There were excessive bubbles in the tubing and the proximal shaft of the jet7 was found to be broken and, therefore, it was removed.The procedure was completed using a new jet7 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The returned jet7 was fractured at approximately 7.0 cm from the hub.The device was kinked at approximately 4.0 cm, 5.0 cm and 9.0 cm from the hub and ovalized at approximately 74.0 cm from the hub.One of the kinks tore the lumen of the jet7.Conclusions: evaluation of the returned jet7 revealed a fracture and kinks near the proximal end.If the device is forcefully advanced against resistance, damage such as kinks may occur.Subsequently, manipulating a kinked device against resistance may result in a kink worsening to a fracture or tearing the jet7 lumen.The kinks likely contributed to the reported excessive bubbling and decreased aspiration.Further evaluation revealed an ovalization on the device and additional kinks.These damages were likely incidental to the reported complaint.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 JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8745260
• Report Number: 3005168196-2019-01280
• Device Sequence Number: 19252619
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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): 05/31/2019
• 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: 11/28/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F87227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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