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

Model Number	PNML6F088904
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
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.
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), a guidewire, a non-penumbra carotid distal protection filter, a non-penumbra carotid stent and a non-penumbra stent.During the procedure, the physician advanced a neuron max into the patient by direct puncture using a dilator and guidewire.Then, after removing the dilator and guidewire, it was noticed that the markerband of the neuron max had detached at the carotid stenosis.Afterwards, the physician placed a carotid distal protection filter and released a carotid stent.Subsequently, the detached markerband was captured inside the filter after manipulation.The procedure was completed by performing a carotid angioplasty, using the same neuron max, the same carotid distal protection filter, and the same carotid stent.After treatment of the carotid stenosis, the physician performed a thrombectomy using the non-penumbra stent.There was no report of an adverse effect to the patient.It was reported that after removing the neuron max post-procedure, it was noticed that the hydrophilic cover of the distal end of the neuron max was peeled off.

• 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: 12072416
• Report Number: 3005168196-2021-01423
• Device Sequence Number: 4765090
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2021
• 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: 08/26/2023
• Device Model Number: PNML6F088904
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/26/2021
• 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: Required Intervention
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005