MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number	24674
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with portal hypertension.The target lesion was located in the hepatic portal vein.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.When dilating the middle part of the covered stent, the mustang balloon failed to deflate even after the pressure was removed.There was no response after multiple attempts, a pump was used to apply more pressure.It was noted that the balloon would continue to inflate with increased pressure but would not deflate during removal.Eventually, a puncture device was used to puncture the balloon and release the pressure.The device was removed and the procedure was completed.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with portal hypertension.The target lesion was located in the hepatic portal vein.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.When dilating the middle part of the covered stent, the mustang balloon failed to deflate even after the pressure was removed.There was no response after multiple attempts, a pump was used to apply more pressure.It was noted that the balloon would continue to inflate with increased pressure but would not deflate during removal.Eventually, a puncture device was used to puncture the balloon and release the pressure.The device was removed and the procedure was completed.No patient complications were reported and the patient status was stable.It was further reported that the inflation device used was an injection syringe and pump and the pressure was held at 6-8 atmospheres.It took 8 to 9 minutes to remove the balloon.The patient did not have any symptoms while the device was inside the body.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 8.0 x 60, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon partial circumferential tear was identified located approximately 3mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.For investigation purposes the investigator dissected the shaft at the strain relief and proximal balloon sleeve.A 0.018" guidewire was inserted through the entire length of the inflation lumen without issue or encountering any obstruction.No issues were found with the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon deflation issue and removal difficulties occurred.The patient presented with portal hypertension.The target lesion was located in the hepatic portal vein.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.When dilating the middle part of the covered stent, the mustang balloon failed to deflate even after the pressure was removed.There was no response after multiple attempts, a pump was used to apply more pressure.It was noted that the balloon would continue to inflate with increased pressure but would not deflate during removal.Eventually, a puncture device was used to puncture the balloon and release the pressure.The device was removed and the procedure was completed.No patient complications were reported and the patient status was stable.It was further reported that the inflation device used was an injection syringe and pump and the pressure was held at 6-8 atmospheres.It took 8 to 9 minutes to remove the balloon.The patient did not have any symptoms while the device was inside the body.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15107699
• Report Number: 2124215-2022-26692
• Device Sequence Number: 19980475
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: 08714729793885
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027616008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 10/06/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/18/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG