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

Model Number H749RB4225100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly calcified and moderately tortuous distal right coronary artery.A 2.25 x 10 flextome¿ cutting balloon¿ catheter was used to dilate the target lesion.During the procedure, it was noted that the balloon ruptured after dilatation of the lesion area.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.The balloon folds were relaxed which may have occurred after the balloon protector was removed from the device.The device was attached to an encore inflation unit and the balloon was inflated without issue to its rated bust pressure of 12 atmospheres.The encore inflation unit was verified using pressure indicator.This was repeated two more times with no inflation or deflation issues noted.No leaks or drops in pressure were noted.The tip, balloon and blades of the device were visually and microscopically examined and no issues were noted that may have potentially contributed to the complaint incident.The hypotube was kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.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 which indicates that the complaint is associated with a product that meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly calcified and moderately tortuous distal right coronary artery.A 2.25 x 10 flextome¿ cutting balloon¿ catheter was used to dilate the target lesion.During the procedure, it was noted that the balloon ruptured after dilatation of the lesion area.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 6184970
• MDR Text Key: 62692728
• Report Number: 2134265-2016-12034
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/09/2016

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: 06/16/2019
• Device Model Number: H749RB4225100
• Device Catalogue Number: RB422510
• Device Lot Number: 19378150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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