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

Model Number 39540

Device Problems Material Perforation (2205); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

It was reported that a hole in the catheter occurred.The totally occluded target lesion was located in the non-tortuous and calcified superficial femoral artery.A 135cm rubicon 35 catheter was selected for use.During an attempt to get through the occlusion, it was noted that the distal end of the catheter folded onto itself, and the wire poked a hole through the catheter.The device was pulled and removed intact from the patients body.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of buckling/kinks located 135cm from the hub.There was a hole in the catheter shaft located 134.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.No other issues were identified during the product analysis.

Event Description

It was reported that a hole in the catheter occurred.The totally occluded target lesion was located in the non-tortuous and calcified superficial femoral artery.A 135cm rubicon 35 catheter was selected for use.During an attempt to get through the occlusion, it was noted that the distal end of the catheter folded onto itself, and the wire poked a hole through the catheter.The device was pulled and removed intact from the patients body.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: RUBICON 35
• Type of Device: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15574359
• MDR Text Key: 301487100
• Report Number: 2124215-2022-40345
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: 08714729832072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0029794642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: Black Or African American