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

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Break (1069); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
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 thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician advanced a neuron max to the target location using a non-penumbra sheath.After successfully aspirated the thrombus using a penumbra system ace 68 reperfusion catheter (ace68) within the neuron max, the physician felt resistance while retracting the neuron max to remove it.Consequently, the radiopaque marker band at the distal end of the neuron max dislodged while the devices were being removed.The marker band migrated and remained stuck in the distal portion of the external carotid artery (eca) and the physician was unable to remove it.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the distal tip of the neuron max was peeled back, and the marker band was missing.The c-cut from where the marker band was laminated into the distal tip of the catheter was visible.There was a small ovalization approximately 77.0 from the hub, 5.0 cm from the distal tip.Conclusions: evaluation of the returned neuron max revealed the distal tip was folded back and the marker band was missing.The distal tip becoming folded is likely due to the interaction of the neuron max with a parent device.The non-penumbra short sheath identified in the complaint was not returned for evaluation; therefore, the root cause of this damage could not be determined.The distal tip folding likely contributed to the detachment of the marker band.Our analysis revealed the c-cut in the neuron max polymer indicating the marker band was fully laminated into the catheter.If the marker band is exposed and forcefully retracted against resistance the marker band may become dislodged.The root cause of the resistance could not be determined.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.

• 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: 7813727
• Report Number: 3005168196-2018-01673
• Device Sequence Number: 14037497
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F78933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005