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

Model Number H7493926715250

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) - attachment: (b)(4).

Event Description

It was reported via medwatch (b)(4) that balloon detachment occurred.The target lesion was located in a non-tortuous, mildly calcified circumflex (cx)/obtuse marginal branch (om) bifurcation.A 2.0 x 15 mm nc emerge balloon was inflated twice at 18 atmospheres.After the lesion was stented, the same 2.0 x 15 nc emerge balloon was advanced but resistance was encountered while trying to cross the stent struts.The balloon was left partially in the om from the cx.A 5.0 x 15 mm nc emerge balloon was advanced to the cx in an attempt to help the 2.0 x 15 mm balloon move forward to dilate the stent struts from the cx.Resistance was encountered on both balloons but the physician did not consider the resistance to be more than usual.The 5.0 balloon was removed and when an attempt was made to remove the 2.5 balloon, the balloon separated inside the patient about 5 mm from where the clear, soft portion of the balloon and the back soft portion started.A wire was twisted around the balloon to get the detached portion into the guide catheter.Another balloon was then inflated at low pressure to pin the broken 2.5 balloon into the guide so it could be removed.The procedure was completed.There were no patient complications and the patient¿s status is fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter in two pieces.The balloon was loosely folded with blood in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The shaft is completely separated 23.8cm from the distal tip.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.The tip is damaged.There are numerous hyptotube and shaft kinks.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported via medwatch # 2300530000-2018-8002 that balloon detachment occurred.The target lesion was located in a non-tortuous, mildly calcified circumflex (cx)/obtuse marginal branch (om) bifurcation.A 2.0x15mm nc emerge balloon was inflated twice at 18 atmospheres.After the lesion was stented, the same 2.0x15 nc emerge balloon was advanced but resistance was encountered while trying to cross the stent struts.The balloon was left partially in the om from the cx.A 5.0x15mm nc emerge balloon was advanced to the cx in an attempt to help the 2.0x15mm balloon move forward to dilate the stent struts from the cx.Resistance was encountered on both balloons but the physician did not consider the resistance to be more than usual.The 5.0 balloon was removed and when an attempt was made to remove the 2.5 balloon, the balloon separated inside the patient about 5mm from where the clear, soft portion of the balloon and the back soft portion started.A wire was twisted around the balloon to get the detached portion into the guide catheter.Another balloon was then inflated at low pressure to pin the broken 2.5 balloon into the guide so it could be removed.The procedure was completed.There were no patient complications and the patient¿s status is fine.

• Brand Name: NC 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: 7332387
• MDR Text Key: 102160841
• Report Number: 2134265-2018-01656
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• 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,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: H7493926715250
• Device Catalogue Number: 39267-1525
• Device Lot Number: 21589535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• 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 Outcome(s): Required Intervention