MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F070956M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2016
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 to treat an arteriovenous malformation (avm) using a neuron 6f 070 delivery catheter (neuron 070).After administrating glue to the patient and upon removal of the neuron 070 from the patient, the physician noticed that the neuron 070 was broken at the hub.Therefore, the procedure was completed using a new neuron 070.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron dc was kinked under the strain relief approximately 1.0 cm from the hub and ovalized approximately 3.0 cm from the distal tip.Conclusions: evaluation of the returned device confirmed it was kinked under the strain relief.This damage likely occurred due to forceful manipulation of the neuron dc proximal shaft during use.Further evaluation revealed the distal shaft was ovalized.This type of damage typically occurs due to forceful gripping or pinching of the neuron dc during preparation or use.Penumbra catheters 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5654343
• Report Number: 3005168196-2016-00668
• Device Sequence Number: 237048
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• 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): 04/15/2016

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: 01/31/2019
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F67539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 06/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR