MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME? CUTTING BALLOON?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H749RB4375100

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in a moderately tortuous and mildly calcified mid right coronary artery.A 10/3.75 flextome¿ cutting balloon¿ was selected for treatment.During procedure, after performing multiple inflations, it was noted that the contrast media leaked into the vessel when attempting to perform additional inflation.It was also suspected that the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported and the patient's condition was good.

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: FLEXTOME? CUTTING BALLOON?
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4454571
• MDR Text Key: 5424972
• Report Number: 2134265-2015-00200
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2017
• Device Model Number: H749RB4375100
• Device Catalogue Number: RB437510
• Device Lot Number: 17081934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2014
• 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: RUN THROUGH; INFLATION DEVICE: ENCORE 26; GUIDING CATHETER: 6F TAIGA JR4; INTRODUCER SHEATH: 6F RADIFOCUS