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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Collapse (1099); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
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 medical procedure in the supraclinoid segment of the internal carotid artery (ica) using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the physician felt resistance but was able to advance the neuron 070 and the microcatheter distal of a 360 degree loop in the patient anatomy.However, the neuron 070 was unable to stay in the target location and retracted to the carotid bulb as the microcatheter was advanced.The physician attempted to advance the neuron 070 twice, however was unsuccessful.The neuron 070 was therefore removed, and the procedure was completed using an indigo system cat5 aspiration catheter (cat5) and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 6f 070 delivery catheter (neuron 070) was kinked in multiple locations.Conclusions: evaluation of the returned device revealed that the neuron 070 was kinked in multiple locations.The distal kinks on the neuron 070 may have been a result of navigating difficulty patient anatomy.Further evaluation revealed several kinks along the length of the catheter.Based on the returned device condition of the device, these kinks were likely incidental.The non-penumbra microcatheter referred to in the complaint was not returned to penumbra for evaluation.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: 7390377
• Report Number: 3005168196-2018-00670
• Device Sequence Number: 16191946
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): N
• 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): 03/05/2018

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: 09/11/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F79465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR