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

Catalog Number	PND6F070956M
Medical Device Problem Codes	Stretched (1601); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 a neuron 6f 070 delivery catheter (neuron 070) was stretched upon removal from the packaging.The damaged neuron 070 was found prior to use and therefore, was not used in the procedure.The procedure completed using a new neuron 070.
Additional Manufacturer Narrative
The packaging tape was torn and removed from the packaging card.The neuron 6f 070 delivery catheter (neuron 070) was stretched approximately 95.0 cm from the hub and ovalized on the distal tip.There were minor bends in the proximal shaft.Evaluation of the returned device revealed the packaging tape was torn and removed from the packaging card, and the distal shaft of the neuron 070 was stretched and ovalized.If the packaging is bent, folded, or otherwise improperly handled, the packaging mandrel placed in the distal shaft of the neuron 070 may slip from under the packaging tape.If an attempt to withdraw the neuron 070 through the packaging tube while the mandrel is still inside the distal shaft is made, the distal shaft may become damaged.The proximal bends were likely incidental and may have occurred during packaging for return to penumbra.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 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7086799
• Report Number: 3005168196-2017-02150
• Device Sequence Number: 1119844
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 08/05/2019
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F70993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1