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

Model Number H7493918908250

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of and emerge balloon catheter device in two pieces.There was blood in the wire lumen, and the balloon was loosely folded.No wire was returned with the device.The tip, balloon, markerbands, inner/outer shaft, port/exit weld, and hypotube were microscopically, tactile and visually inspected.Inspection revealed a complete separation in the outer shaft at the proximal end of the port/exit notch weld, numerous kinks in the hypotube, inner shaft(wire lumen) bunched up in numerous areas (inside of balloon and general shaft area), balloon damage (tear-1mm), tip damage (flared and smashed), and port weld damage (stretched).Measurements were difficult to discern, due to the extensive damage to the entire device.The damage to the inner shaft, tip, and port weld are consistent with a guide wire becoming stuck in the device during a procedure.Functional testing could not be done due to the extensive device damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The emerge mr balloon catheter dfu includes the following warning: "if resistance is felt during manipulation, determine the cause of the resistance before proceeding." (b)(4).

Event Description

It was reported that catheter entrapment and balloon detachment occurred.After a guide wire crossed the lesion, a 2.50mm x 8mm emerge¿ balloon catheter was advanced for dilatation; however, difficulty advancing over the wire was encountered.Eventually, the lesion was dilated.However, upon removal of the balloon, difficulty was noted and it got sheared.The devices had to be removed together.No patient harm nor complications 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: 7238655
• MDR Text Key: 99197304
• Report Number: 2134265-2018-00406
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2020
• Device Model Number: H7493918908250
• Device Catalogue Number: 39189-0825
• Device Lot Number: 21252020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• 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