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

Catalog Number	PND6F070956
Medical Device Problem Codes	Collapse (1099); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron 6f 070 delivery catheter (neuron 070).During the procedure, the physician was unable to advance the neuron 070 into its introducer sheath.The physician used a guidewire to try to advance the neuron 070, however was still unable to advance into the introducer sheath.The physician then attempted to advance the neuron 070 into the non-penumbra catheter without using the introducer sheath and, consequently, the neuron 070 crumpled.The procedure was then completed using a new neuron 070 with its introducer sheath and the same catheter.There was no report of an adverse effect to the patient.

• 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: 7557754
• Report Number: 3005168196-2018-01081
• Device Sequence Number: 13921206
• Product Code: DQY
• UDI-Device Identifier: 00814548010069
• UDI-Public: 00814548010069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 11/29/2020
• Device Catalogue Number: PND6F070956
• Device Lot Number: F80790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/31/2018
• 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