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

Model Number H749RB4225060

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that saline leak occurred.The 50% stenosed target lesion was located in a coronary artery.A 2.25mmx06mm flextome cutting balloon was selected for use.During procedure, it was noted that the device was leaking saline.Procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: device as returned for analysis.The device was received in two separate pieces for analysis.A visual and tactile examination identified a break in the hypotube approximately 710mm distal of the strain relief.A hypotube kink was also noted approximately 755mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.The balloon folds were observed to be relaxed which may have occurred when the balloon protector was removed.There was no evidence that the balloon had been subjected to positive pressure.No issues were identified with the balloon that may have contributed to the compliant incident.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that saline leak occurred.The 50% stenosed target lesion was located in a coronary artery.A 2.25mmx06mm flextome¿ cutting balloon¿ was selected for use.During procedure, it was noted that the device was leaking saline.Procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 7106217
• MDR Text Key: 94794143
• Report Number: 2134265-2017-12489
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 11/27/2017

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: 02/09/2020
• Device Model Number: H749RB4225060
• Device Catalogue Number: RB422506
• Device Lot Number: 0020269481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• 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