MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493919315350

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of an emerge balloon catheter with an unidentified stopcock attached to the hub.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The device was hooked up to an inflation device containing water and the device leaked water from the shaft at the exit notch.There is damage and a puncture hole in the shaft at the exit notch causing the device to leak at that location.The damage at the exit notch is consistent with damage that is caused by the guidewire.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that shaft leak occurred.During preparation of a 3.50mm x 15mm emerge¿ balloon catheter, leakage of contrast media occurred near the exit port of the guide wire.It appeared that there was a hole on the device.The procedure was completed with a non-bsc balloon catheter.No patient complications nor injuries were reported.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7277903
• MDR Text Key: 100513005
• Report Number: 2134265-2018-00922
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: H7493919315350
• Device Catalogue Number: 39193-1535
• Device Lot Number: 21117568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2017
• 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