MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F0701058M
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2018
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 medical procedure using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the neuron 070 became kinked as the physician was advancing it within the internal carotid artery (ica) loop, and therefore the neuron 070 was removed.The procedure was completed using a new neuron 070 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 070 was ovalized approximately 17.5 cm from the hub and kinked approximately 113.5 cm from the hub.Bends were present along the length of the device.The packaging mandrel was unsecure from the packaging tape.Conclusions: evaluation of the returned neuron 070 revealed a kinked and ovalized device.Damage such as kinks may have occurred due to forceful advancement of the neuron 070 within difficult patient anatomy.Further evaluation revealed an ovalization.This type of damage typically occurs due to improper handling during use.If the device is forcefully gripped or pinched during insertion or further manipulation, damage such as ovalization may occur.Further evaluation revealed the packaging mandrel was unsecure from the packaging tape.If the packaging mandrel becomes unsecure during removal of the device from the packaging, it could pin the device between the packaging tube and the packaging mandrel.If the device is retracted while pinned, this could contribute to the observed damage.Further evaluation revealed bends along the length of the device.Based on the return condition and the reported complaint, the bends are likely incidental to the reported case and may have occurred during packaging for return to penumbra.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.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7520674
• Report Number: 3005168196-2018-00989
• Device Sequence Number: 1438349
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018
• 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: Physician
• Device Expiration Date: 08/23/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F78829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005