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

Model Number	39540
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that reported that catheter perforation occurred.The target lesion was highly stenosed and was located in the moderately to severely tortuous and severely calcified left common femoral artery (cfa), left superficial femoral artery (sfa) and popliteal arteries (pop).A rubicon 35, 135cm was selected for treatment.The physician attempted to cross the iliac bifurcation to advance wire down left lower extremity prior to long sheath placement but was unsuccessful.The rubicon device was removed intact, but it was found to be kinked and had a hole in it.Another of the same device was used with a glide wire to cross through the chronic total occlusion (cto) at the cfa and advance down the sfa.The physician used a 260cm amplatz wire for additional support to upsize the sheath to 7fr for an atherectomy device.Upon removing the rubicon, it was stuck on the wire, so it was taken out of the sheath but still remained stuck and appeared stretched.The physician decided to cut the proximal portion of the rubicon device from the wire to avoid losing wire access in the lesion.When the 7fr sheath was placed, the amplatz was replaced with different device before placing a v-18 guidewire.The procedure was successfully completed with no complications reported.
Additional Manufacturer Narrative
The device was returned for evaluation.The shaft and tip were microscopically and visually inspected.Visual examination of the returned rubicon revealed multiple kinks and a hole in the shaft.Microscopic inspection revealed a hole to the shaft 11.5cm from the tip.The remainder of the device presented no other damage or irregularities.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that reported that catheter perforation occurred.The target lesion was highly stenosed and was located in the moderately to severely tortuous and severely calcified left common femoral artery (cfa), left superficial femoral artery (sfa) and popliteal arteries (pop).A rubicon 35, 135cm was selected for treatment.The physician attempted to cross the iliac bifurcation to advance wire down left lower extremity prior to long sheath placement but was unsuccessful.The rubicon device was removed intact, but it was found to be kinked and had a hole in it.Another of the same device was used with a glide wire to cross through the chronic total occlusion (cto) at the cfa and advance down the sfa.The physician used a 260cm amplatz wire for additional support to upsize the sheath to 7fr for an atherectomy device.Upon removing the rubicon, it was stuck on the wire, so it was taken out of the sheath but still remained stuck and appeared stretched.The physician decided to cut the proximal portion of the rubicon device from the wire to avoid losing wire access in the lesion.When the 7fr sheath was placed, the amplatz was replaced with different device before placing a v-18 guidewire.The procedure was successfully completed with no complications reported.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19995967
• Report Number: 2124215-2024-50236
• Device Sequence Number: 8363288
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0033151519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: 5FR X65CM BERN CATHETER.; CATHETER: 5FR X65CM BERN CATHETER.; GUIDEWIRE: 035 X 260CM AMPLATZ, V-18.; GUIDEWIRE: 035 X 260CM AMPLATZ, V-18.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White