MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F SELECT CATHETER; DQY

Catalog Number	PNS6F125H1
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2017
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 numbers: 3005168196-2018-00287; 3005168196-2018-00288; 3005168196-2018-00289.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using neuron 6f select catheters (6f selects) and neuron max 6f 088 long sheaths (neuron maxs).During the procedure, the physician was unable to advance a 6f select into a neuron max.The physician, therefore, replaced the rotating hemostatic valve (rhv); however, was still unable to advance the 6f select into the neuron max.The 6f select and the neuron max were therefore removed, and a new neuron max was placed inside the patient.The physician was then unable to advance a new 6f select into the new neuron max, and therefore, the neuron max and the 6f select were removed.The procedure was then completed using a third 6f select and a third neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the neuron 6f select catheter (6f select).The outer diameter (od) of the first 6f select was measured using a ring gauge and was determined to be out of specification.Conclusions: evaluation of the first 6f select revealed no visible damage to the device.The 6f select od was measured using a ring gauge and determined to be out of specification.The od of the first evaluated 6f select likely contributed to the difficulty experienced while advancing through the neuron max 6f 088 long sheath (neuron max).Evaluation of the second 6f select revealed no visible damage to the device.The 6f select od was measured using a ring gauge and was determined to be within specification.The 6f select was advanced through the returned neuron max with resistance and out of the distal tip.Evaluation of the returned neuron max revealed no visible damage.A stainless steel mandrel was advance through the hub of the neuron max and out of the distal tip without an issue.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 numbers: 3005168196-2018-00287, 3005168196-2018-00288, 3005168196-2018-00289.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7245732
• Report Number: 3005168196-2018-00286
• Device Sequence Number: 11056385
• Product Code: DQY
• UDI-Device Identifier: 00814548012087
• UDI-Public: 00814548012087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083125
• 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): 01/08/2018

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: Physician
• Device Expiration Date: 12/08/2019
• Device Catalogue Number: PNS6F125H1
• Device Lot Number: F73056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR