MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE RUBICON¿ 35; CATHETER, PERCUTANEOUS

Model Number H74939240035151

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 that the catheter was perforated.The target lesion was located in the right superficial femoral artery (sfa).During procedure, a 150cm rubicon¿ 35 and a non bsc guide wire encountered difficulty in advancing through the sfa.Upon removal of the catheter, it was noted that the non bsc guide wire perforated the catheter causing a segment of the catheter hanging.Both devices were then removed from the patient's body completely and completed the procedure with another of the same device.There were no patient complications and the patient's condition was fine.

• Brand Name: RUBICON¿ 35
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6303236
• MDR Text Key: 66554901
• Report Number: 2134265-2017-00663
• Device Sequence Number: 1
• Product Code: DQY
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: H74939240035151
• Device Catalogue Number: 39240-03515
• Device Lot Number: 19972185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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: 93 YR