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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and removal difficulty occurred.The 50% stenosed target lesion was located in the non-tortuous and non-calcified pulmonary vein.A 10.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.Inflation was performed three times at 14 atmospheres for 7 seconds.However, during the third inflation, the balloon ruptured and a pinhole was noted in the middle of the balloon.The physician tried to remove the device normally but could not pull it into the sheath and was stuck.The chest was surgically opened and the shaft of the device was cut to retrieve it.The procedure was not completed as same device was unavailable.No further complications were reported.
Event or Problem Description
It was reported that balloon rupture and removal difficulty occurred.The 50% stenosed target lesion was located in the non-tortuous and non-calcified pulmonary vein.A 10.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.Inflation was performed three times at 14 atmospheres for 7 seconds.However, during the third inflation, the balloon ruptured and a pinhole was noted in the middle of the balloon.The physician tried to remove the device normally but could not pull it into the sheath and was stuck.The chest was surgically opened and the shaft of the device was cut to retrieve it.The procedure was not completed as same device was unavailable.No further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 10.0 x 20, 75cm was received for analysis.The device was received in two sections due to a complete shaft break and balloon circumferential tear.The 6rf sheath used by the customer was returned with the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Two complete balloon circumferential tears were identified.The first tear was located at the proximal balloon sleeve.The second tear was located approximately 20mm distal of the first.Both sections of balloon material were noted to have been pushed distally towards the tip of the device.The type of damage is consistent with resistance being encountered and excessive force being applied when withdrawing the device through the sheath/guide.No other issues were noted with the balloon material.A visual examination observed damage to the tip of the device.This type of damage is consistent with resistance being encountered and excessive force being applied to the device.A visual and tactile examination found the shaft of the device to have completely detached at the proximal balloon bond.This type of damage is consistent with resistance being encountered excessive tensile force being applied to the device when withdrawing it through the sheath.A visual examination found that both markerbands had moved on the shaft of the device.This most probably occurred due to damage to the shaft.
Event or Problem Description
It was reported that balloon rupture and removal difficulty occurred.The 50% stenosed target lesion was located in the non-tortuous and non-calcified pulmonary vein.A 10.0 x 20, 75cm mustang balloon catheter was advanced for dilatation.Inflation was performed three times at 14 atmospheres for 7 seconds.However, during the third inflation, the balloon ruptured and a pinhole was noted in the middle of the balloon.The physician tried to remove the device normally but could not pull it into the sheath and was stuck.The chest was surgically opened and the shaft of the device was cut to retrieve it.The procedure was not completed as same device was unavailable.No further complications were reported.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13518423
• Report Number: 2134265-2022-00803
• Device Sequence Number: 14764498
• Product Code: FGE
• UDI-Device Identifier: 08714729793601
• UDI-Public: 08714729793601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/15/2022

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: 10/15/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026190446
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown