MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY MUSTANG¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number H74939171060470

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon pinhole occurred.The target lesion was located in a laryngeal vessel.A 6.0 x 40 75cm mustang¿ balloon catheter was advanced for dilation.However, upon inflation, it appeared to have a hole in it.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device confirmed that the balloon was unfolded and inflation media was noted within the balloon which indicates that the balloon had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was observed escaping from a pinhole leak approximately 3mm proximal to the proximal edge of the distal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination found no issues with the markerbands or tip which could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was further reported that the inflation failed and the saline leaked out of a hole that was visually seen.

• Brand Name: MUSTANG¿
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6993463
• MDR Text Key: 91357773
• Report Number: 2134265-2017-10790
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: ZA
• PMA/PMN Number: K110122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: H74939171060470
• Device Catalogue Number: 39171-06047
• Device Lot Number: 19626593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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