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

Model Number H74939171100410

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a shaft hole occurred.A 7f introducer sheath was introduced without difficulty, then a 10.0 x 40 135cm mustang¿ balloon catheter was advanced for dilation; however, during inflation, it was noted that the pressure on the inflation device did not rise above 10 points and that contrast was noted in patient's vein during fluoroscopy.The device was removed and a small hole was observed at the junction between the shaft and the balloon.No patient complications were reported.

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 had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied when a pinhole leak was identified in the balloon material approximately 11mm proximal to the proximal edge of the proximal markerband.A visual and microscopic examination of the balloon identified no issues with the balloon material that have contributed to the balloon damage.A visual and microscopic examination found no issue with the markerbands of the device which could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the tip that 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 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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a shaft hole occurred.A 7f introducer sheath was introduced without difficulty, then a 10.0 x 40 135cm mustang balloon catheter was advanced for dilation; however, during inflation, it was noted that the pressure on the inflation device did not rise above 10 points and that contrast was noted in patient's vein during fluoroscopy.The device was removed and a small hole was observed at the junction between the shaft and the balloon.No patient complications were reported.

• Brand Name: MUSTANG¿
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7481225
• MDR Text Key: 107161888
• Report Number: 2134265-2018-03893
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K110122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: H74939171100410
• Device Catalogue Number: 39171-10041
• Device Lot Number: 0020998695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1