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

Catalog Number	PND6F070956M
Medical Device Problem Codes	Out-Of-Box Failure (2311); Difficult to Open or Remove Packaging Material (2922); Failure To Unwrap (2940)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2015
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
During preparation for a medical procedure, the hospital staff noticed that the packaging mandrel of a neuron 6f 070 delivery catheter (neuron 070) was stuck and unable to be removed upon removal of the neuron 070 from its packaging.The defective neuron 070 was found prior to use and was not used for the procedure.The procedure continued using a new neuron 070.
Additional Manufacturer Narrative
Result: the neuron delivery catheter 070 (neuron 070) was stretched approximately 5.0 cm from the distal tip; the distal shaft was also ovalized approximately 0.3 and 7.5 cm from the distal tip.Conclusion: evaluation of the returned device revealed that the distal shaft of the neuron 070 was kinked and ovalized.This type of damage may be caused due to removal of the device from the packaging against resistance.If the distal tip of the catheter is pinned underneath the blank label that is used to hold the packaging mandrel to the packaging card, resistance may be experienced when the neuron dc is pulled from the packaging tube.These devices are 100% visually inspected for damage during 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: 5349429
• Report Number: 3005168196-2016-00039
• Device Sequence Number: 18915389
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Report Date (Section B): 10/30/2015

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: 04/30/2018
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F63733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1