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

Model Number H7493895912250

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The balloon was loosely folded with blood in the lumen and contrast in the balloon.The balloon, markerbands, proximal bond and tip were microscopically inspected.The device was attached with an inflation device filled with water and brought to rated burst pressure (rbp).The balloon easily inflated and held pressure (without leaking) for 5 minutes.Microscopic examination of the device presented no irregularities or defects.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 a balloon pinhole occurred.The target lesion was located in the coronary artery.A 2.50mm x 12mm apex balloon catheter was advanced to dilate the lesion.However, the balloon did not inflate.The physician felt like it had a micro puncture on the balloon.The device was removed completely and the procedure was completed with a 2.25x12mm apex balloon catheter.No patient complications were reported and the patient's status was fine.

• Brand Name: APEX¿
• 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: 5959799
• MDR Text Key: 55042174
• Report Number: 2134265-2016-08236
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: H7493895912250
• Device Catalogue Number: 38959-1225
• Device Lot Number: 19408322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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