MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was defective.A 150 cm rubicon 35 was selected for use.There were "barbs" noted on the outside of the device when the device should be smooth.It was reported that the "barbs" could cause vessel damage.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter was defective.A 150cm rubicon 35 was selected for use.There were "barbs" noted on the outside of the device when the device should be smooth.It was reported that the "barbs" could cause vessel damage.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a rubicon 35.Visual examination of the device showed damage in the form multiple small protrusions on the outside of the shaft from the tip proximal 21cm.The shaft was also kinked at 1.5cm from the tip.A hole was noticed located 10cm from the tip.Presence of blood was noticed on the device.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8822379
• Report Number: 2134265-2019-08668
• Device Sequence Number: 2838508
• Product Code: DQY
• UDI-Device Identifier: 08714729832058
• UDI-Public: 08714729832058
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 02/07/2022
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0023317208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1