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

Model Number	H74938046760750
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon separation occurred.A 7.0x60x75cm express® ld iliac / biliary stent was advanced to treat a lesion.However, while inside the sheath, the balloon material came off the shaft of the catheter and it detached completely off the system.The device was retrieved without problems.The procedure was completed with another of the same device.There was no sequelae with the patient and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr: the delivery system was returned with the stent fully detached from the balloon material and in two separate pieces.The stent was not returned for analysis.No additional information was provided in respect to the location of the stent, however further information has been requested.One section consisted on balloon, markerbands, balloon bonds and tip.The other section consisted of catheter and the hub/manifold.A visual and tactile examination identified complete detachment of the balloon material at the location of the proximal balloon bond.A microscopic examination of the proximal balloon bond and catheter noted evidence of excessive tensile force having been applied to the device.Severe stretching damage was identified on both the catheter and proximal balloon bond which had detached with the balloon material.Kinking damage was also noted on the catheter of the device.The damage noted it consistent with excessive force having been applied to the device in a pulling motion, this may have occurred during removal of the device.The balloon material was bunched up and solidified blood was noted on the outside of the material.Due to the condition of the returned device is was not possible to inflate the balloon, however a visual and microscopic examination of the balloon material identified no tears or damage.Additional analysis was performed and the balloon was submerged in water to assess if bubbles were created when the material was palpitated.As no bubbles were identified this also indicated the balloon material was undamaged.No issues were noted with the catheter, balloon bond or balloon material that could have contributed to the complaint incident.The distal balloon bond was intact and undamaged.A visual and microscopic examination identified no issues with the tip or markerbands that could have contributed to the complaint incident.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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that balloon separation occurred.A 7.0x60x75cm express® ld iliac / biliary stent was advanced to treat a lesion.However, while inside the sheath, the balloon material came off the shaft of the catheter and it detached completely off the system.The device was retrieved without problems.The procedure was completed with another of the same device.There was no sequelae with the patient and the patient was fine.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7321306
• Report Number: 2134265-2018-01703
• Device Sequence Number: 110508
• Product Code: NIO
• UDI-Device Identifier: 08714729392231
• UDI-Public: 08714729392231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 02/13/2018

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: 11/12/2020
• Device Model Number: H74938046760750
• Device Catalogue Number: 38046-76075
• Device Lot Number: 0021376052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1