MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 14; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically inspected for damage.The devices shaft showed extreme damage in the form of bends kinks and buckling.The kink was located at 120cm from the hub.There was severe stretching starting at 119.5cm from the hub and traveled distally towards the tip.There was a separation located 166.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 25jan2022.It was reported that a microwire was difficult to remove from the catheter.The 100% occluded target lesion was located in the non tortuous and non calcified tibialis anterior dextra.A 150cm rubicon 14 was selected for use.During the procedure, at the time of angiography evaluation, the microwire was difficult to remove from the rubicon 14 microcatheter so it broke on the rubicon 14 microcatheter.The device was removed via jr 6fr guide catheter and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was a separation located 166.5cm from the hub.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.The device was visually and microscopically inspected for damage.The devices shaft showed extreme damage in the form of bends kinks and buckling.The kink was located at 120cm from the hub.There was severe stretching starting at 119.5cm from the hub and traveled distally towards the tip.There was a separation located 166.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 25jan2022.It was reported that a microwire was difficult to remove from the catheter.The 100% occluded target lesion was located in the non tortuous and non calcified tibialis anterior dextra.A 150cm rubicon 14 was selected for use.During the procedure, at the time of angiography evaluation, the microwire was difficult to remove from the rubicon 14 microcatheter so it broke on the rubicon 14 microcatheter.The device was removed via jr 6fr guide catheter and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was a separation located 166.5cm from the hub.

• Brand Name: RUBICON 14
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13546430
• Report Number: 2134265-2022-01640
• Device Sequence Number: 5060486
• Product Code: DQY
• UDI-Device Identifier: 08714729799085
• UDI-Public: 08714729799085
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K112303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 05/18/2024
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0027341919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female