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

Catalog Number	PNS5F120SIM
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the 5f select was fractured approximately 116.5 cm from the hub at the distal catheter joint.The 5f select was kinked approximately 110.0 cm from the hub.The distal fractured segment was ovalized approximately 1.0 cm from the fracture.Conclusions: evaluation of the returned 5f select confirmed a fractured device.Damage such as this may occur if force in excess of the tensile strength of the material bond is placed on the device when navigating in anatomy.Some anatomy may be more tortuous which may also contribute to this type of device damage.Further evaluation revealed an ovalization on the proximal end of the distal fractured portion.This damage was likely a result of the snaring process and is consistent with the location and orientation of the device.The non-penumbra sheath used in the procedure was not returned for evaluation.Therefore, it was unable to be evaluated for damage that may have also contributed to the reported 5f select failure.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.
Event or Problem Description
The patient was undergoing a diagnostic procedure using a neuron select catheter 5f (5f select) through a 5f sheath via radial approach.During the procedure, the 5f select fractured inside the patient.The proximal end of the fractured segment was snared and successfully removed from the patient¿s body.The procedure was completed using another catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 mfr report:3005168196-2018-02434 and is being corrected on this follow-up #02 mfr report: 3005168196-2018-02434.Additional narrative and/or corrected data.Please note that the following section was missed on the initial report and is being corrected on this follow-up #01 mfr report: 3005168196-2018-02434.Outcomes attributed to adverse event.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8166541
• Report Number: 3005168196-2018-02434
• Device Sequence Number: 16830728
• Product Code: DQY
• UDI-Device Identifier: 00814548010205
• UDI-Public: 00814548010205
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2021
• Device Catalogue Number: PNS5F120SIM
• Device Lot Number: F85965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 06/12/2019; 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005