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

Model Number M001103320

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that a balloon ruptured, catheter removal difficulties were encountered, and shaft break occurred.The 90% stenosed target lesion was located in a shunt in a moderately tortuous and moderately calcified vessel.A 0-4/4t/90mm symmetry¿ balloon catheter was advanced for pre-dilatation.However, upon the third inflation at 15 atmospheres, the balloon ruptured.When the physician attempted to remove the ruptured balloon, severe sheath resistance was felt and the device was unable to be removed.During that time, the balloon catheter got detached.Another sheath was placed and the detached catheter was retrieved using a snare.The detached piece of the device that was seen under fluoroscopy was removed.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: two separate sections of the device were received for analysis.One section consisted of balloon material and shaft, this section was returned still trapped within the snare.The main section of the device consisted shaft, hub/manifold, the balloon bond and a small section of balloon material.The balloon was received in two different sections.The balloon material detached approximately 12mm distal to the proximal balloon bond at the point of a complete circumferential tear in the balloon.Approximately 12mm of balloon material was left attached the distal shaft.The detached section of the balloon material was removed from the snare.This section of balloon material was approximately 35mm in length; however the material was severely creased and bunched together due to the snaring and solidified blood.A visual and microscopic examination of the balloon material still attached the distal shaft identified no issues that could have contributed to the complaint incident.A complete break was identified in the shaft of the device 61mm distal to the circumferential balloon tear.The balloon shaft also appeared to be stretched.Multiple kinks were also noted on the shaft of the device.A visual and microscopic examination of the break site noted that excessive tensile force had been applied to the device which may have occurred when difficulty was encountered removing the device.An examination identified no issues with the returned shaft that could have contributed to the complaint incident.In order to enable a detailed examination of the tip and markerbands the severely bunched up balloon material was dissected with the use of a blade from the detached section of shaft.A visual and microscopic examination identified that the proximal markerband and distal tip of the device were not inside the balloon material and had not been returned for analysis.The distal markerband was intact and undamaged.The detachment of the proximal makerband and tip may have occurred when the physician applied excessive tensile force which resulted in the severe shaft damage and the requirement of a snare to remove the detached section 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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a balloon ruptured, catheter removal difficulties were encountered, and shaft break occurred.The 90% stenosed target lesion was located in a shunt in a moderately tortuous and moderately calcified vessel.A 0-4/4t/90mm symmetry balloon catheter was advanced for pre-dilatation.However, upon the third inflation at 15 atmospheres, the balloon ruptured.When the physician attempted to remove the ruptured balloon, severe sheath resistance was felt and the device was unable to be removed.During that time, the balloon catheter got detached.Another sheath was placed and the detached catheter was retrieved using a snare.The detached piece of the device that was seen under fluoroscopy was removed.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

• Brand Name: SYMMETRY¿
• 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: 7119247
• MDR Text Key: 94923550
• Report Number: 2134265-2017-12339
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K953602
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: M001103320
• Device Catalogue Number: 10-332
• Device Lot Number: 0020661666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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