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

Model Number M001103270

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon rupture, removal difficulties and distal tip detachment occurred.The 90% stenosed, 20mm in length and 5.0mm in diameter target lesion was located in the moderately tortuous vein in a forearm.A 4/4t/90 symmetry balloon catheter was advanced for pre-dilation.However, on the first inflation at 15 atmospheres, the balloon ruptured transversely after being inflated for 30 seconds.Upon attempt to withdraw the device the device could not be removed from the sheath and the distal tip of the device got detached and remained inside the patient's body.The sheath was then replaced with a 6f sheath and the detached tip was retrieved with the use of a snare device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device identified that a complete circumferential tear had occurred in the balloon.The tear was located at 9mm distal to the proximal edge of the proximal balloon sleeve.The distal section of the balloon was trapped in a snare and pushed through a section of a 6french sheath.A break was evident in the shaft at 17mm proximal to the tip.An examination of the broken sections of the shaft identified that the shaft was severely stretched.This damage is consistent with excessive tensile force having been applied to the shaft.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, removal difficulties and distal tip detachment occurred.The 90% stenosed, 20mm in length and 5.0mm in diameter target lesion was located in the moderately tortuous vein in a forearm.A 4/4t/90 symmetry¿ balloon catheter was advanced for pre-dilation.However, on the first inflation at 15 atmospheres, the balloon ruptured transversely after being inflated for 30 seconds.Upon attempt to withdraw the device the device could not be removed from the sheath and the distal tip of the device got detached and remained inside the patient's body.The sheath was then replaced with a 6f sheath and the detached tip was retrieved with the use of a snare 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5217882
• MDR Text Key: 30970050
• Report Number: 2134265-2015-07667
• 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: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2018
• Device Model Number: M001103270
• Device Catalogue Number: 10-327
• Device Lot Number: 17645447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60