MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE RUBICON¿ 18; CATHETER, PERCUTANEOUS

Model Number H74939239018131

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported foreign matter inside device.During an angioplasty case, the physician was using a rubicon catheter through a non bsc sheath and the rubicon flushed okay.It was removed and the sheath was switch for a 5fr non bsc 45cm sheath.The rubicon was advanced again but would not flush at all.It was thought to have been caused by a kink, however; once it was removed and inspected that as not the case.A guidewire was advanced through the rubicon and a small hard blue piece of foreign matter came out.They were not sure if it was from the rubicon or from the second sheath.No patient complications were reported.

Manufacturer Narrative

Updated:describe event or problem.(b)(4).

Event Description

It was further reported the physician was working in the tibial vessels.

• Brand Name: RUBICON¿ 18
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5274128
• MDR Text Key: 32918164
• Report Number: 2134265-2015-08481
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: H74939239018131
• Device Catalogue Number: 39239-01813
• Device Lot Number: 17958114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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
• Treatment: BIOTRONIK 5 FR FORTRESS SHEATH 45CM