MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number H74938046860750

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon deflation failure and removal difficulty occurred.An 8.0x60x75cm express® ld stent was deployed to the lesion.However, when the stent delivery system (sds) was removed, the balloon would not come back through the 7f non-bsc sheath as the balloon was still in a deflated state but not fully.A cut down was performed to remove the not fully deflated balloon and the procedure was completed.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(6).Age at time of event, age at time of event (unit), describe event or problem, other relevant history, init reporter sent to fda, complaint source(s), device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the device was received partially withdrawn through a 7french size sheath.The mid to distal end of the balloon was exiting the sheath.The sheath was severely stretched and accordioned.As a result the express device could not be withdrawn.The sheath was dissected in order to expose the balloon fully.The sheath was dissected in order to expose the balloon fully.There was a large build-up of blood inside the balloon.This blood is consistent with a device leak.The device was attached to an encore inflation unit, subjected to positive pressure and three balloon pinholes were identified.Three pinhole leaks were found between 4mm and 7mm distal to the proximal markerband.A visual and microscopic examination found no issue with the profile of the markerbands.No issues were noted with the profile of the shaft.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 via user facility medwatch (b)(4) that a 7f non-bsc introducer sheath was used with the stent/balloon catheter.When deflating and attempting to pull out the balloon catheter, the balloon would not pull thru the sheath.The sheath and the balloon catheter were removed together over the wire.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• 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: 5738909
• MDR Text Key: 47849072
• Report Number: 2134265-2016-05284
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090003
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Model Number: H74938046860750
• Device Catalogue Number: 38046-86075
• Device Lot Number: 0018101003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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: 70 YR