MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5f select was ovalized approximately 93.0 thru 99.5 cm from the hub.Conclusions: evaluation of the returned 5f select revealed that the catheter shaft was ovalized.If the device is forcefully retracted out of its packaging at extreme angles or otherwise mishandled during preparation, damage such as this may occur.Penumbra catheters are visually 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.
Event or Problem Description
During preparation for a medical procedure, the physician found that the neuron select catheter 5f (5f select) was flattened in the extremity upon removal from the packaging.The damage to the 5f select was found prior to use.Therefore, the 5f select was not used in the procedure.The procedure was completed using a new 5f select.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7749488
• Report Number: 3005168196-2018-01518
• Device Sequence Number: 16570457
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2018
• 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: 03/21/2021
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F82488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/03/2018
• 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