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

Model Number H749RB4250100

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The tip section of the device was visually and microscopically examined and no issues were noted.An examination of the returned device found a break in the hypotube.The break was located at 714mm distal to the strain relief.Multiple kinks were observed along both sections of the hypotube.An examination of the distal extrusion found that the extrusion was bunched just proximal to the balloon.The balloon folds were relaxed.The balloon and blades of the device were visually and microscopically examined and no issues were noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 06-dec-2016.It was reported that the catheter had difficulty crossing the lesion.The 85% stenosed target lesion was located in the severely tortuous and moderately calcified left circumflex artery.A 2.50 x 10mm flextome¿ cutting balloon¿ was selected for use.During procedure, it was noted that the device failed to cross the target lesion.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.However, device analysis revealed a break in the hypotube at 714mm distal to the strain relief.

• Brand Name: FLEXTOME¿ CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6186341
• MDR Text Key: 62790880
• Report Number: 2134265-2016-11854
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2016

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: 07/17/2017
• Device Model Number: H749RB4250100
• Device Catalogue Number: RB425010
• Device Lot Number: 17132729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• 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: ENTRO 2.0*15MM
• Patient Age: 71 YR