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

Model Number H74939206051510

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter entrapment and shaft break occurred.The target lesion was located in the shallow femoral right lower limb artery.The lesion had a previously implanted stent.A 5.0 x150, 135cm charger balloon catheter was advanced for pre-dilation.After the lesion was fully expanded, the balloon could not be pulled out.The whole guide wire and the balloon were then removed however, it was noted that shaft near the hub of the balloon catheter had fractured.No segment of the balloon was retained inside the patient's body.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was received in two sections as a result of a break in the shaft.The break location was 58.2cm proximal to the tip.The shaft at the break site was severely stretched and bunched.The proximal section of the shaft break was severely stretched down onto a guidewire.It was not possible to remove the wire as the shaft was stretched down onto the wire.Due to the severely stretched and damaged shaft, it was not possible determine the location / cause of the initial wire restriction.The balloon was not refolded.No other issues were observed with the balloon and 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 catheter entrapment and shaft break occurred.The target lesion was located in the shallow femoral right lower limb artery.The lesion had a previously implanted stent.A 5.0 x150, 135cm charger¿ balloon catheter was advanced for pre-dilation.After the lesion was fully expanded, the balloon could not be pulled out.The whole guide wire and the balloon were then removed however, it was noted that shaft near the hub of the balloon catheter had fractured.No segment of the balloon was retained inside the patient's body.No patient complications were reported and the patient's status was 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: 6147570
• MDR Text Key: 61542198
• Report Number: 2134265-2016-11167
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2016

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: 04/19/2019
• Device Model Number: H74939206051510
• Device Catalogue Number: 3920605151
• Device Lot Number: 0019164513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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 Age: 72 YR