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

Catalog Number	PNS6F125H1
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2016
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.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron 6f select catheter (6f select).During the procedure, the 6f select was unable to fit into another manufacturer's sheath, therefore it was removed.The procedure was completed using another manufacturer's catheter and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: there was no visible damage to the penumbra neuron 6f select (6f select).The non-penumbra device was kinked approximately 19.5 and 45.5 cm from the hub.A 0.040 inch stainless steel mandrel was introduced through the hub of the 6f select.The 6f select and mandrel were introduced through the hub of a neuron max 088 (neuron 088) and advanced distally out the distal tip without an issue.The 6f select outer diameter (od) was verified using a ring gauge and the device met the specification.Conclusion: evaluation of the returned device revealed that the 6f select was used with a non-penumbra device that had an inner diameter (id) of less than or equal to 0.087.This is likely the reason the 6f select did not fit into non-penumbra device.The 6f select was advanced through the hub of a neuron 088 and out the distal tip without an issue.The 6f select od was measured using a ring gauge and passed without an issue.All 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 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5766439
• Report Number: 3005168196-2016-00923
• Device Sequence Number: 10763757
• Product Code: DQY
• UDI-Device Identifier: 00814548012087
• UDI-Public: 00814548012087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070970
• 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): 06/03/2016

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: 04/08/2019
• Device Catalogue Number: PNS6F125H1
• Device Lot Number: F68877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR