MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the catheter tip peeled off and was retrieved by snare.The target lesion was located in the moderately tortuous and severely calcified artery anterior tibial artery (ata).A 90cm rubicon 18 was selected for use.During procedure, a.014 non-bsc wire was exchanged to 300cm v-18 wire with the rubicon support catheter.V-18 wire was positioned distally, and the catheter was removed.However, the catheter did not move up and the tip peeled off and became stuck in the ata.Subsequently, a snare catheter was tried to channel down but there were a lot of restrictions as the angle of the lesion was acute and the proximal part of the trifurcation was perforated.A larger sheath size and a covered stent were then used to stop the perforation.Then, the rubicon catheter tip was retrieved using a snare catheter.Balloon angioplasty was completed, but the flow was not ideal as the diagnostic run.The procedure was stopped, and the puncture point was closed.No further complications were reported and the patient was stable.
Event or Problem Description
It was reported that the catheter tip peeled off and was retrieved by snare.The target lesion was located in the moderately tortuous and severely calcified artery anterior tibial artery (ata).A 90cm rubicon 18 was selected for use.During procedure, a.014 non-bsc wire was exchanged to 300cm v-18 wire with the rubicon support catheter.V-18 wire was positioned distally, and the catheter was removed.However, the catheter did not move up and the tip peeled off and became stuck in the ata.Subsequently, a snare catheter was tried to channel down but there were a lot of restrictions as the angle of the lesion was acute and the proximal part of the trifurcation was perforated.A larger sheath size and a covered stent were then used to stop the perforation.Then, the rubicon catheter tip was retrieved using a snare catheter.Balloon angioplasty was completed, but the flow was not ideal as the diagnostic run.The procedure was stopped, and the puncture point was closed.No further complications were reported and the patient was stable.It was further reported that a 9-15mm x 120cm non bsc snare system was used to retrieve the tip of the rubicon catheter.
Additional Manufacturer Narrative
A1.Patient identifier- (b)(6).A2: age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for evaluation.Visual examination of the device showed damage in the form of stretching, kinks and a separation.The separated component showed multiple kinks.The separation was located 14cm from the tip.A.018 test guidewire was inserted into the catheter shaft through the hub end.The guidewire transcended through the shaft until the stretched area where the guidewire stopped.The location of the stretched area was 73cm from the hub.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9175665
• Report Number: 2134265-2019-12232
• Device Sequence Number: 17054771
• Product Code: DQY
• UDI-Device Identifier: 08714729829232
• UDI-Public: 08714729829232
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K122394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 04/17/2022
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0023662611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WIRE- .014 ABBOTT WIRE; WIRE- .014 ABBOTT WIRE; WIRE- 300CM V-18; WIRE- 300CM V-18; WIRE- .014 ABBOTT WIRE; WIRE- 300CM V-18
• Outcome Attributed to Adverse Event: Required Intervention