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

Model Number H7493895908250

Device Problems Hole In Material (1293); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.A 2.50mm x 8mm apex¿ balloon catheter was selected to dilate to lesion.During preparation, it was noted that the balloon had a hole after it was hooked up on an unspecified inflation device.The device was not inflated and the device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an apex balloon catheter with no other devices.The balloon was loosely folded.The device was inflated to rated burst pressure with an inflation device filled with water; no issues were encountered during inflation.The device maintained rbp for five (5) minutes with no indication of any leaks or other irregularities.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.A 2.50mm x 8mm apex balloon catheter was selected to dilate to lesion.During preparation, it was noted that the balloon had a hole after it was hooked up on an unspecified inflation device.The device was not inflated and the device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3866896
• MDR Text Key: 4505017
• Report Number: 2134265-2014-03277
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2014

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: 02/13/2017
• Device Model Number: H7493895908250
• Device Catalogue Number: 38959-0825
• Device Lot Number: 16742658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1