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

Model Number H7493918912200

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported that balloon pin hole occurred.A 2.00mm x 12mm emerge¿ balloon catheter was selected.When the device was inflated, a hole was noted on the device.The procedure was completed with a 3.0 x12mm quantum apex balloon catheter.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of emerge balloon catheter with no other devices.There was blood and contrast in the inflation lumen.The device was pressurized with an inflation device filled with water.A pinhole was identified in the balloon wall adjacent to the proximal edge of the proximal markerband.Microscopic examination of the balloon presented no irregularities in the balloon material that could have contributed to the damage.Microscopic examination of the markerbands presented no irregularities that could have contributed to the damage.No proximal weld damage was found on the proximal bond.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 pin hole occurred.A 2.00mm x 12mm emerge¿ balloon catheter was selected.When the device was inflated, a hole was noted on the device.The procedure was completed with a 3.0 x12mm quantum apex balloon catheter.No patient complications were reported and the patient's status was fine.

• 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: 4080705
• MDR Text Key: 4899299
• Report Number: 2134265-2014-05376
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2017
• Device Model Number: H7493918912200
• Device Catalogue Number: 39189-1220
• Device Lot Number: 17048717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR