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

Model Number H7493895912200

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

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon pinhole occurred.A 2.00 mm x 12 mm apex¿ balloon catheter was selected for use to dilate a lesion.However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted.The device was not used inside the patient and the procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of a apex balloon catheter.The balloon was loosely folded with contrast in the balloon and lumen.There were numerous hypotube kinks.There was tip damage.Functional testing with an inflation filled with water was used to inflate the balloon to the rated burst pressure and revealed no damages.Inspection of the proximal and distal markerband did not reveal any damages.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 2.00mm x 12mm apex balloon catheter was selected for use to dilate a lesion.However, when the balloon was flushed and prepped, it was felt that the balloon material was compromised and a pinhole was noted.The device was not used inside the patient and 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6511278
• MDR Text Key: 73390383
• Report Number: 2134265-2017-03854
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: (01)08714729475477(17)20200131(10)20203773
• 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,Followup
• Report Date: 04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 20203773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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