MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM REPERFUSION CATHETER 026; NRY

Catalog Number	PSC026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the catheter 026 was fractured at the hub underneath the strain relief.The proximal end of the fractured device was reinserted into the hypotube to verify the location of the fracture.The inner catheter lumen displayed torqueing and twisting damage.The device was ovalized approximately 147.5 cm and 150.5 cm from the hub.Conclusions: evaluation of the returned catheter 026 revealed a fracture under the id band at the hub of the device.This damage was likely a result of excessive torqueing while advancing the device.The twisting and fraying of the catheter and liner observed at the fracture site suggests this was a torqueing failure.Further evaluation revealed ovalization on the distal portion of the device.Based on the reported complaint, this damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system reperfusion catheter 026 (catheter 026).During the procedure, while advancing the catheter 026 through a neuron max 6f 088 long sheath (neuron max), the catheter 026 broke approximately five centimeters from its hub; therefore, it was removed.The procedure was completed using a new catheter 026 and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM REPERFUSION CATHETER 026
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8203112
• Report Number: 3005168196-2018-02518
• Device Sequence Number: 233926
• Product Code: NRY
• UDI-Device Identifier: 00814548010304
• UDI-Public: 00814548010304
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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
• Report Date (Section B): 11/28/2018
• 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 Expiration Date: 08/28/2020
• Device Catalogue Number: PSC026
• Device Lot Number: F78925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005