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

Model Number 7162

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter facility name: (b)(6).Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.Visual examination revealed multiple kinks along the hypotube and the hypotube appears to be twisted.Microscopic examination revealed that the tip is damaged.There is contrast present in the inflation lumen and balloon.The balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing and was able to pass thru.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that catheter entrapment occurred.The chronic totally occluded target lesion was located in the moderately tortuous right coronary artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, on the 8th inflation at 10 atmospheres, the device became stuck with the guidewire.The procedure was completed with a 2.0 non-bsc device and no patient complications were reported.

• 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: 8343838
• MDR Text Key: 136283765
• Report Number: 2134265-2019-01182
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 7162
• Device Catalogue Number: 7162
• Device Lot Number: 0022738911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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