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

Catalog Number	5MAXJETD
Medical Device Problem Code	Break (1069)
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
Additional 510(k)# that also applies to this complaint: k133317.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 middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician made a pass using the jetd with a neuron max 6f 088 long sheath (neuron max).However, while retracting, the jetd tip broke off inside the distal end of the neuron max.Therefore, the neuron max was removed with the broken tip inside.The procedure was completed using a new jetd and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jetd was fractured approximately 131.0 cm from the hub.The jetd was kinked approximately 12.0, 17.0, 19.0, 77.5, and 82.0 cm from the hub.The jetd was ovalized approximately 73.0 and 122.0 thru 128.0 cm from the hub.The jetd started to stretch approximately 129.0 cm from the hub.Conclusions: evaluation of the returned jetd confirmed that the catheter was fractured.If the catheter is retracted against resistance, damage such as fracture may occur.The neuron max identified in the complaint was not returned for evaluation; therefore, the root cause of resistance could not be determined.During the functional test, the damaged jetd was advanced through a demonstration neuron max without an issue.Further evaluation of the returned jetd revealed that the catheter was kinked, ovalized, and stretched.The stretching likely occurred from retracting against resistance prior to the fracture.The kinks and ovalization were likely incidental to the reported complaint.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.H3 other text : placeholder.

• 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: 9214128
• Report Number: 3005168196-2019-01958
• Device Sequence Number: 2388214
• Product Code: NRY
• UDI-Device Identifier: 00814548019734
• UDI-Public: 00814548019734
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 09/22/2019
• 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: 12/11/2021
• Device Catalogue Number: 5MAXJETD
• Device Lot Number: F87490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/22/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005