MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939206070410

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was returned for analysis.No issues were noted with the tip section of the device.An examination of the balloon identified a longitudinal tear in the balloon material.The tear was located along the main body of the balloon and it for a total length of 3cm in length.It was noted that there was a large build-up of blood inside the balloon.A visual and microscopic examination of the markerbands found no issues with the profiles of the markerband.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.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

Reportable based on analysis completed on (b)(4) 2015.It was reported that balloon damage occurred.A 7.0mmx40mm, 135cm charger balloon catheter was selected.During preparation of the device, it was noticed that the balloon was did not look right and defective.The device never entered the patient's body.The procedure was completed using another 7.0mmx40mm, 135cm charger balloon catheter.No patient complications were reported.However, returned device analysis revealed a longitudinal balloon tear.

• Brand Name: CHARGER¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5305645
• MDR Text Key: 33724544
• Report Number: 2134265-2015-08682
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2018
• Device Model Number: H74939206070410
• Device Catalogue Number: 3920607041
• Device Lot Number: 17957857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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