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

Model Number H7493919315300

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.The 90% stenosed target lesion was located in the non calcified left anterior descending artery (lad).A 3.00mm x 15mm emerge¿ balloon catheter was selected to dilate the lesion.During the first inflation, the balloon leaked at 6 atmospheres after being inflated for 10 seconds.Angiography revealed contrast leakage.When the device was removed, pinhole was noted on the balloon.The procedure was completed with a different device.No patient complications were noted and the patient's status was good.

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).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The catheter was inspected tactilely and under magnification.There was contrast in the inflation lumen and in the balloon.The inner shaft was kinked from the distal tip and the distal tip was damaged.Inspection of the balloon revealed no damage or irregularities.The catheter was soaked in a warm water bath to loosen the contrast prior to functional testing.Functional testing was performed using an inflation device filled with water.The catheter was pressurized to 14atm and no leak in the balloon or shaft was noted.Deflation was attempted; however, the balloon did not deflate on multiple attempts.In this case, the kinked shaft and contrast in the lumen may have caused inflation lumen restriction which is a known factor for inhibiting balloon deflation.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 manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that balloon pinhole occurred.The 90% stenosed target lesion was located in the non calcified left anterior descending artery (lad).A 3.00mm x 15mm emerge balloon catheter was selected to dilate the lesion.During the first inflation, the balloon leaked at 6 atmospheres after being inflated for 10 seconds.Angiography revealed contrast leakage.When the device was removed, pinhole was noted on the balloon.The procedure was completed with a different device.No patient complications were noted and the patient's status was good.

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3866607
• MDR Text Key: 4457090
• Report Number: 2134265-2014-03641
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2016
• Device Model Number: H7493919315300
• Device Catalogue Number: 39193-1530
• Device Lot Number: 16492442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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