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

Catalog Number	PNML6F088804
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00323.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 kit and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician reported feeling resistance while advancing the penumbra system jet 7 reperfusion catheter (jet7) through the neuron max.Additionally, the jet7 was unable to advance through the neuron max into the target vessel.The physician then decided to remove the jet7 and completed the procedure using a smaller catheter and the same neuron max.There was no report of an adverse effect to the patient.Upon examination of the devices after the case, the physician found that the distal end of the neuron max hub had become kinked, and had prevented the jet7 from advancing.It was also reported that the kink in the neuron max likely occurred during positioning.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 1.5 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed that the catheter was kinked.If the device is forcefully advanced against resistance during use or positioning, damage such as a kink may occur.Evaluation of the returned jet7 revealed no issue with the catheter.The jet7 was advanced through a demonstration catheter and out of the distal tip without an issue.The kink in the neuron max likely contributed to the reported resistance and prevented the jet7 from being advanced through the neuron max during the procedure.The non-penumbra catheter 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.This report is associated with mfr report number: 3005168196-2019-00323.

• 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: 8361420
• Report Number: 3005168196-2019-00322
• Device Sequence Number: 13931897
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019
• 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: 10/29/2021
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F86711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005