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

Model Number H7493919312220

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge balloon catheter.There was blood in the inflation lumen and balloon.The balloon was tightly folded.Microscopic examination presented no damage or irregularities with the bonds.Tactile inspection and microscopic examination revealed that the outer and inner shafts were torn 7mm distal of the exit notch.The damage is consistent with interaction with another device.There were numerous kinks throughout the shaft.Microscopic examination presented no irregularities in the shaft material that could have contributed to the damage.Tactile inspection and microscopic examination presented no damage or irregularities to the hypotube.Functional testing was performed by attaching an inflation device filled with water to the hub of the device.When positive pressure was applied, a stream of water emitted from the tear in the shaft wall.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 15-mar-2016.It was reported that shaft leak occurred.The target lesion was located in a coronary artery.A 2.25mm x 12mm emerge¿ balloon catheter was advanced for dilatation.However, during inflation, water was noted to be leaking from the hypotube.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, returned device analysis revealed outer and inner shaft tear.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5548204
• MDR Text Key: 41904326
• Report Number: 2134265-2016-02844
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: H7493919312220
• Device Catalogue Number: 39193-1222
• Device Lot Number: 17438604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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