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

Catalog Number	PNML6F088904
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2019
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: 3005168196-2019-00887.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician felt resistance and was unable to advance a jet7 through a neuron max and, therefore, the jet7 and neuron max were removed.It was reported that the jet7 was found to be kinked.The procedure was then completed using a new neuron max and a penumbra system ace 68 reperfusion catheter (ace68).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned neuron max 6f 088 long sheath (neuron max) was undamaged.Conclusions: evaluation of the returned neuron max revealed an undamaged device.No visible damage was observed on the catheter and a 0.088¿ mandrel was able to insert into the catheter without an issue.Evaluation of the returned jet7 revealed a kink and ovalizations on its distal shaft.During functional testing, resistance was experienced while advancing the jet7 through a demonstration neuron max due to the ovalizations.The kink prevented the jet7 from advancing farther.Forcefully gripping the catheter during removal from the package or preparation may result in damage such as ovalizations.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 number: 3005168196-2019-00887.

• 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: 8588263
• Report Number: 3005168196-2019-00886
• Device Sequence Number: 13869929
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/07/2019
• 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: 01/16/2022
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F88035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005