MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYMMETRY¿ 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H7493918755200

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the severely calcified cephalic vein.A 5.5-2/4t/40 symmetry¿ 40 balloon catheter was advanced for dilation.However, when the balloon was inflated at 15 atmospheres, the balloon ruptured.There was a probability that a segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another 5.5-2/4t/40 symmetry¿ 40 balloon catheter.There were no patient complications nor injury reported.

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device identified a large circumferential tear 3mm distal of the proximal markerband with the tear extending longitudinally 10mm distally in the balloon material.The balloon was fully attached to the device and upon a visual examination of the balloon, there was no evidence that suggests balloon material detached from the device.An examination of the distal markerband identified no issues.A visual examination of the shaft identified no issues.Blood was identified in the lumen 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

It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the severely calcified cephalic vein.A 5.5-2/4t/40 symmetry¿ 40 balloon catheter was advanced for dilation.However, when the balloon was inflated at 15 atmospheres, the balloon ruptured.There was a probability that a segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another 5.5-2/4t/40 symmetry¿ 40 balloon catheter.There were no patient complications nor injury reported.

• Brand Name: SYMMETRY¿ 40
• 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: 6401607
• MDR Text Key: 69839703
• Report Number: 2134265-2017-02048
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2017
• Device Model Number: H7493918755200
• Device Catalogue Number: 39187-5520
• Device Lot Number: 17410064
• 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: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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
• Treatment: INTRODUCER SHEET: MOSQUITO
• Patient Outcome(s): Other