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

Model Number 7133

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed that the tip is damaged.There is a pinhole in the balloon 5mm from the tip.There is blood present in the guide wire lumen and balloon.The device was placed into a water bath to soften the dried blood in the device so a functional test could be performed.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A.014 test guide wire was advanced into the guide wire lumen and was unable to pass the kinks in the guide wire lumen.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 07-jan-2019.It was reported that tip damage occurred and advancing difficulties were encountered.The 95% stenosed, 2.5x15mm was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, it was noted that the tip of the balloon was damaged and the device could not reach the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a balloon pinhole.

• 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: 8283320
• MDR Text Key: 134305003
• Report Number: 2134265-2019-00483
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/28/2019

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: 10/12/2020
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0021753592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 66