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

Model Number H7493895815150

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2014

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred.A 1.50mm x 15mm apex¿ flex balloon catheter was advanced to dilate the lesion.The balloon was inflated; however a pinhole was noted in the balloon and leaked was also noticed.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that during the first inflation, balloon pinhole was noted.The device was completely removed from the patient and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an apex balloon catheter with no other devices.There was blood in the inflation lumen and balloon.Microscopic examination of the balloon did not reveal any damage or irregularities.Functional testing was performed by connecting a water filled inflation device to the device.As pressure was applied water exited out of a pinhole in the shaft 6.5cm proximal of the proximal balloon bond.There was no evidence of any material or manufacturing deficiencies.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 further reported that during the first inflation, balloon pinhole was noted.The device was completely removed from the patient and the patient's status was fine.

• Brand Name: APEX? FLEX
• 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: 4207504
• MDR Text Key: 5148109
• Report Number: 2134265-2014-06894
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: H7493895815150
• Device Catalogue Number: 38958-1515
• Device Lot Number: 17283247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1