MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 9.5, 72.0 cm from the hub.The neuron max was ovalized approximately 29.0, 56.0, 74.0, and 78.0 cm from the hub.The neuron max was kinked approximately 9.5, 72.0 cm from the hub.The neuron max was ovalized approximately 29.0, 56.0, 74.0, and 78.0 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed that the device was kinked and ovalized.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the neuron max revealed that the device was ovalized.If the device is forcefully gripped or pinched during handling, damage such as ovalization may occur.Some of this damage was likely incidental to the reported issue and may have occurred while packaging the device for return to penumbra.The sheath identified 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.
Event or Problem Description
During preparation for a medical procedure, the tip of a neuron max 6f 088 long sheath (neuron max) became kinked as the physician attempted to advance it through a sheath.The damage to the neuron max occurred prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using a new neuron max and the same sheath.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7652758
• Report Number: 3005168196-2018-01300
• Device Sequence Number: 11217179
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 03/28/2020
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F75276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1