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

Model Number H74939222352010

Device Problems Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an agent dcb.The balloon was tightly folded and was not damaged.The tip/shaft bond was separated and was not returned for analysis.There were numerous kinks throughout the hypotube.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

Reportable based on the product analysis completed on august 9th, 2016.During unpacking of the 3.50 mm x 20.00 mm agent drug coated balloon (dcb) catheter, the balloon seemed to be stuck to the plastic protector so when they removed the protector, the balloon was damaged.Different device was used to complete the case.However, the returned product analysis revealed that the distal tip was detached.

• Brand Name: AGENT
• 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: 5921530
• MDR Text Key: 53717307
• Report Number: 2134265-2016-07980
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: H74939222352010
• Device Catalogue Number: 39222-35201
• Device Lot Number: 6727H15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• 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