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

Model Number H74938047840130

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the balloon failed to deflate.The target lesion was located in the right common iliac artery.An 8.0x40x135 cm express(tm) ld iliac / biliary stent was deployed at 8 atmospheres.However, post stent deployment, the bottom third of the balloon would not deflate.The physician then attempted to pull the device out of the sheath and the balloon started to deflate.The device was successfully removed and the procedure was completed.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method code, result code, conclusion code updated.Device evaluated by mfr.: as part of the device analysis, the device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure with no leaks or drop in pressure noted.The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.Using the same encore, a vacuum was pulled and the balloon fully deflated in 10 seconds.This inflate to rated burst pressure and deflation fully under vacuum was repeated on three more occasions and on each occasion the balloon maintained pressure with no leaks noted and fully deflated fully in an average time of 10 seconds which is within specification.The deflation time was recorded using the digital timer.A visual examination of the returned device found no damage along the shaft.No other issues were noted during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that the balloon failed to deflate.The target lesion was located in the right common iliac artery.An 8.0x40x135 cm express ld iliac / biliary stent was deployed at 8 atmospheres.However, post stent deployment, the bottom third of the balloon would not deflate.The physician then attempted to pull the device out of the sheath and the balloon started to deflate.The device was successfully removed and the procedure was completed.No patient complications were reported and the patient's status was fine.

• 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: 5790419
• MDR Text Key: 49419434
• Report Number: 2134265-2016-06779
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: H74938047840130
• Device Catalogue Number: 38047-84013
• Device Lot Number: 0018982288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• 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: 73 YR