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

Model Number H7493919320300

Device Problem Deflation Problem (1149)

Patient Problems Non specific EKG/ECG Changes (1817); Pain (1994)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4),.

Event Description

It was reported that balloon deflation failure occurred and the patient experienced pain.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.00mm x 20mm emerge¿ balloon catheter was advanced for dilatation.During inflation, the physician noted that the balloon took much longer to inflate than the normal and thought there was no contrast in it.After an unspecified time, the balloon inflated to 6 atmospheres.However, when deflation was attempted, the balloon would not deflate even after pulling negative pressure on the inflator.Subsequently, the inflation device was removed and the physician attempted to manually deflate the balloon with a syringe but was unsuccessful.The patient started complaining of increasing pain and electrocardiogram (ecg) changes were noted as the balloon was blocking the lad.The physician was able to pull the still inflated balloon from the proximal lad and out through the guide catheter.No damages were noted to the lad or left main vessels.The physician was then able to continue placing a stent and the procedure was completed.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.:returned product consisted of the emerge balloon catheter.The shaft, hypotube, welds, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded and deflated when received.There were numerous kinks throughout the hypotube of the device.There was moderate stretching of the outer/inner.Functional testing was performed by attaching an inflation device filled with water to hub of the device.When positive pressure was applied, the balloon inflated right away and the catheter maintained constant pressure and there was no indication of any leaks or other anomalies.After confirming that device maintained rated burst pressure (rbp), an attempt to deflate the device by applying negative pressure with the inflation device was made; however, the device did not deflate.Inspection of the remainder of the device, 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

It was reported that balloon deflation failure occurred and the patient experienced pain.The target lesion was located in the proximal left anterior descending (lad) artery.A 3.00mm x 20mm emerge¿ balloon catheter was advanced for dilatation.During inflation, the physician noted that the balloon took much longer to inflate than the normal and thought there was no contrast in it.After an unspecified time, the balloon inflated to 6 atmospheres.However, when deflation was attempted, the balloon would not deflate even after pulling negative pressure on the inflator.Subsequently, the inflation device was removed and the physician attempted to manually deflate the balloon with a syringe but was unsuccessful.The patient started complaining of increasing pain and electrocardiogram (ecg) changes were noted as the balloon was blocking the lad.The physician was able to pull the still inflated balloon from the proximal lad and out through the guide catheter.No damages were noted to the lad or left main vessels.The physician was then able to continue placing a stent and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• 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: 6560501
• MDR Text Key: 74942566
• Report Number: 2134265-2017-05056
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H7493919320300
• Device Catalogue Number: 39193-2030
• Device Lot Number: 20294124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Required Intervention