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

Model Number H74939240035131

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: over 60.(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

Same case as: 2134265-2018-05473.It was reported that the guidewire perforated a hole in the catheter.The target lesion was located in the right and left common iliac/aorta.An amplatz super stiff guidewire, zipwire hydrophilic guide wire, starter guidewire and a non-bsc wire were selected for use.During the procedure, the first 135cm rubicon¿ 35 was flushed with saline and an attempt to pass the catheter from the right common iliac over to the left common iliac was made; however the device was getting "hang-up" and the anatomy was noted to be very difficult.The catheter would not track and became difficult to remove over the zipwire hydrophilic guide wire.The rubicon and the wire were removed.A second 135cm rubicon¿ 35 was selected for use with the same zipwire and amplatz super stiff guidewire used with the first rubicon device.It was noted that the amplatz wire felt different and perforated through the middle of the catheter about three quarters down and did not come out the end hole.The rubicon was removed.A bsc bern catheter and a non-bsc catheter were also selected for use.A wire and the bern catheter were successfully used to access the superficial femoral artery.Balloon angioplasty was performed of the left superficial femoral artery.No patient complications were reported and the patient's status if 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: 7615084
• MDR Text Key: 111555013
• Report Number: 2134265-2018-05472
• 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: 05/30/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: H74939240035131
• Device Catalogue Number: 39240-03513
• Device Lot Number: 21927608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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: GUIDEWIRE: ROSEN