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

Catalog Number	PND6F070956M
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2017
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 the tip of the neuron 6f 070 delivery catheter (neuron 070) was kinked.The damage to the neuron 070 was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Results: the neuron 070 had multiple kinks near the hub, and the packaging card was bent.The packaging mandrel was shifted distal from its original position, leaving the distal end of the neuron 070 under the packaging tape.Conclusions: evaluation of the returned device revealed it was kinked in multiple locations near the hub.This damage may have occurred due to forceful handling of the neuron 070 at extreme angles during removal from the packaging.Further evaluation revealed the packaging card was bent and the packaging mandrel was shifted distal to its original position.If the proximal end of the packaging card is impacted, it may cause the neuron 070 and packaging mandrel to shift distally on the packaging card.If the distal end of the neuron 070 becomes shifted underneath the packaging tape, resistance may be experienced upon attempting to withdraw the neuron 070, and the neuron 070 may become damaged.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: 6457110
• Report Number: 3005168196-2017-00537
• Device Sequence Number: 10981712
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: 11/29/2019
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F72904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1