MAUDE Adverse Event Report: PENUMBRA, INC. NEURON DELIVERY CATHETER 053; DQY

Catalog Number	PND6F11512
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2017
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 distal end of a neuron delivery catheter 053 (neuron 053) was ovalized upon removal from the packaging.The damage to the neuron 053 was found prior to use; therefore, it was not used in the procedure.The procedure was completed using a new neuron 053.
Additional Manufacturer Narrative
Results: the device was kinked approximately 4.0, 21.0, 44.0, 72.0, 99.0, and 114.0 cm from the hub.Conclusions: evaluation of the returned neuron delivery catheter 053 (neuron 053) revealed poor return packaging resulting in several kinks along the catheter length.Due to this returned damaged, we could not confirm the reported damage or its associated root cause.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 DELIVERY CATHETER 053
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6675165
• Report Number: 3005168196-2017-01048
• Device Sequence Number: 2059443
• Product Code: DQY
• UDI-Device Identifier: 00814548010120
• UDI-Public: 00814548010120
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K070970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: PND6F11512
• Device Lot Number: F47585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1