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

Model Number	H74938047740130
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the guidewire used by the customer was not returned.A 0.035inch guide wire was loaded without issue and passed through the lumen without any resistance encountered.It was noted that the stent had moved 3mm proximally on the device.The stent was not loose on the balloon and did not move freely.No issues were noted with the balloon.This type of damage is consistent with the application of excessive force to the system.A visual inspection of the stent and the balloon identified no issues that may have contributed to this complaint.A visual and tactile examination of the catheter identified no issues along the length 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 or Problem Description
Reportable based on analysis completed on 07-mar-2017.It was reported that catheter tracking difficulties over the guide wire were encountered.The target lesion was located in the superior mesenteric artery (sma).After a guide wire crossed the lesion, a 7.0x40x135 cm express® ld iliac / biliary stent was advanced however, the device would not pass over the wire.It kept hanging up on the same spot on the wire.The device was removed from the patient's body.The procedure was completed with another guide wire and another 7.0x40x135 cm express® ld iliac / biliary stent.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed stent movement on balloon.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6429557
• Report Number: 2134265-2017-02326
• Device Sequence Number: 602734
• Product Code: NIO
• UDI-Device Identifier: 08714729392446
• UDI-Public: (01)08714729392446(17)20190615(10)19373051
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2019
• Device Model Number: H74938047740130
• Device Catalogue Number: 38047-74013
• Device Lot Number: 19373051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR