MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7162

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Event Description

It was reported that balloon incorrect length occurred.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, during procedure the balloon appears longer under fluoroscopy than the stated 2.50mm x 12mm length.The balloon was inflated several times over rated burst pressure to 20 atmospheres.The procedure was completed with this device.No patient serious injury or adverse event were reported and the patient's status was fine.Device evaluated by manufacturer: the returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.There were numerous hypotube kinks throughout the device and the tip was damaged.Functional testing was performed by placing a test guidewire in the wire lumen and connected an inflation device filled with water to the inflation port to emerge device.The device was inflated to nominal pressure and was microscopically inspected.The balloon was found to be deformed/stretched and the wire lumen was found to be stretched.The balloon was measure with a stainless steel ruler and found to be approximately 16mm.The deform/stretching of the balloon and inner shaft is consistent to damaged caused by over inflating the device several times.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8160819
• MDR Text Key: 130228855
• Report Number: 2134265-2018-63670
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: 7162
• Device Catalogue Number: 7162
• Device Lot Number: 0022422277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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