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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: k133317.Results: the jetd was kinked approximately 25.5, 31.0 thru 33.0, 98.0, and 148.0 cm from the hub.Conclusions: evaluation of the returned jetd revealed that the catheter was kinked.If the catheter is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered as the kink in the jetd was advanced through the hub of the demonstration neuron max and, therefore, the jetd could not be advanced any further.The neuron max identified in the complaint was not returned to penumbra for evaluation.The root cause of the resistance experienced during the procedure could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician made two passes using the jetd.After the second pass, the physician noticed that the jetd was kinked.It was reported that the physician had felt resistance while advancing the jetd within the neuron max 6f 088 long sheath (neuron max).Therefore, the jetd was removed and the procedure was completed using a new jetd, the same neuron max, non-penumbra microcatheter, and stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8081767
• Report Number: 3005168196-2018-02264
• Device Sequence Number: 2321937
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• 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): 10/18/2018
• 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 Catalogue Number: 5MAXJETDKIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005