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

Catalog Number	PND6F070956M
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that device code (b)(4) also applies to this complaint.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 the tip of the neuron 6f 070 delivery catheter (neuron 070) became detached from the shaft of the catheter after the protective mandrel was removed from the cardboard backing and pulled away from the tip of the neuron 070.As a result of the neuron 070 tip detaching, the braiding wire within the neuron 070 began to unravel.The scrub nurse stated that the end of the neuron 070 was securely stuck to the mandrel.The damaged neuron 070 was found prior to use and was not used for the procedure.
Additional Manufacturer Narrative
Result: the neuron 6f 070 delivery catheter (neuron 070) was fractured approximately 96.5 cm from the hub.Adhesive residue was observed on the packaging mandrel.Conclusion: evaluation of the returned device confirmed that the distal tip of the neuron 070 was fractured from the catheter shaft and the coil wire was unraveling.This type of damage typically occurs due to improper handling during removal from the packaging card.If the distal tip of the neuron 070 is restrained during removal of the catheter from its packaging, this type of damage may occur.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report:(b)(4).1.Section g.Box 4.Date received by manufacturer h3 other text : placeholder.

• 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: 5552669
• Report Number: 3005168196-2016-00432
• Device Sequence Number: 16230458
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2016
• Report Date (Section F): 01/01/2005

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: 09/30/2018
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F65597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided; 08/09/2016
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 09/02/2016; 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005