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

Model Number H74939206080870

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon detachment occurred.The target lesion was located in the fistula of the arm vein.An 8.0 x80, 75cm charger¿ balloon catheter was advanced for dilation.However, upon removal of the device, part of the balloon was detached from the catheter as it was coming out from the sheath.The detached portion of the balloon was completely removed using a retrieval device and the procedure was completed.No patient complications were reported and the patient's status was fine and stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination confirmed that a break in the shaft occurred 5mm proximal from the proximal end of balloon.Bunching was also observed at 395mm and 580mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the delivery system during use.The customer guidewire was returned and still in device.The outer diameter of the guidewire was measured at 0.0339 inches.The catheter is compatible with 0.035 inch guidewires.The balloon was crumbled and stained with dried blood.The balloon was visually inspected and no tears or damage was observed.The introducer sheath used by the customer was not returned for analysis.No other issues were noted with the device.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 reported that balloon detachment occurred.The target lesion was located in the fistula of the arm vein.An 8.0 x80, 75cm charger¿ balloon catheter was advanced for dilation.However, upon removal of the device, part of the balloon was detached from the catheter as it was coming out from the sheath.The detached portion of the balloon was completely removed using a retrieval device and the procedure was completed.No patient complications were reported and the patient's status was fine and stable.

• Brand Name: CHARGER¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6384269
• MDR Text Key: 69259208
• Report Number: 2134265-2017-01663
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2020
• Device Model Number: H74939206080870
• Device Catalogue Number: 3920608087
• Device Lot Number: 20203516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• 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
• Patient Outcome(s): Required Intervention