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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/28/2019
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.This report is associated with mfr report numbers: 3005168196-2019-00853; 3005168196-2019-00854; 3005168196-2019-00855.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance and was unable to advance a penumbra system ace 68 reperfusion catheter (ace68) into the neuron max.The physician then found that the neuron max was kinked approximately 40 cm from the proximal end.The neuron max was therefore removed and was no longer used in the procedure.The physician then found that three additional neuron maxs were kinked in the same location upon removal from the packaging and during visual inspection, respectively.These neuron maxs were not used in the procedure.The procedure was completed using another neuron max and the same ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 76.0 cm from the hub.The packaging tube was slightly kinked.Conclusions: evaluation of the neuron max used in the procedure confirmed a kinked device.If the neuron max is mishandled during preparation, or advanced at extreme angles into a parent device, damage such as kinks may occur.If a kinked neuron max is used in the procedure, resistance may be experienced while advancing another device through it.During functional testing, a demonstration catheter was advanced through the neuron max used in the procedure and resistance was experienced at the neuron max kink location.Evaluation of the other three returned neuron maxs confirmed kinked devices.If the neuron maxs are mishandled during preparation, damage such as kinks may occur.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.This report is associated with mfr report numbers: 1.(b)(4) 2.(b)(4) 3.(b)(4) h3 other text : placeholder.

• 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: 8574023
• Report Number: 3005168196-2019-00856
• Device Sequence Number: 2267827
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/03/2019
• 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: 09/04/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F85666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005