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

Model Number	24673
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, shaft break, and balloon detachment occurred requiring an additional intervention.The patient underwent percutaneous transluminal angioplasty (pta).The 80% stenosed target lesion was located in the non-tortuous and mildly calcified arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During inflation, the balloon did not inflate evenly and on the third inflation at 16 atmospheres, the balloon ruptured in left subclavian vein.When the physician tried to remove the device through the jugular sheath, the balloon material was stuck at the sheath.As a result, the balloon catheter broke in half leaving the part of the catheter and the torn balloon pieces inside the patient.Subsequently, the physician punctured on the right femoral artery with a 16 french sheath.After angiography, a minor vessel injury was observed.The device was successfully removed by snare.The procedure was increased by three hours and was completed with another of same device.The patient was sent to emergency room for monitoring possible complications.
Event or Problem Description
It was reported that balloon rupture, shaft break, and balloon detachment occurred requiring an additional intervention.The patient underwent percutaneous transluminal angioplasty (pta).The 80% stenosed target lesion was located in the non-tortuous and mildly calcified arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During inflation, the balloon did not inflate evenly and on the third inflation at 16 atmospheres, the balloon ruptured in left subclavian vein.When the physician tried to remove the device through the jugular sheath, the balloon material was stuck at the sheath.As a result, the balloon catheter broke in half leaving the part of the catheter and the torn balloon pieces inside the patient.Subsequently, the physician punctured on the right femoral artery with a 16 french sheath.After angiography, a minor vessel injury was observed.The device was successfully removed by snare.The procedure was increased by three hours and was completed with another of same device.The patient was sent to emergency room for monitoring possible complications.It was further reported that the patient condition was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 7.0 x 200, 75cm, was received for analysis.The device was received in two sections due to device separation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 70mm distal of the proximal balloon sleeve.This type of damage most probably occurred when the device was being withdrawn through the sheath.The rated burst pressure for this device as per mustang specification.A visual examination observed damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination found the shaft of the device to have completely detached at two locations.The first break was located approximately 100mm distal of the proximal balloon sleeve.The second break was located approximately 25mm proximal of the distal balloon bond.The middle section of shaft which detached between both markerband was not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found one of the markerbands to have moved distally on the device towards the tip.The markerband displacement most probably occurred due to the severe shaft damage causing it to loosen and move.
Event or Problem Description
It was reported that balloon rupture, shaft break, and balloon detachment occurred requiring an additional intervention.The patient underwent percutaneous transluminal angioplasty (pta).The 80% stenosed target lesion was located in the non-tortuous and mildly calcified arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During inflation, the balloon did not inflate evenly and on the third inflation at 16 atmospheres, the balloon ruptured in left subclavian vein.When the physician tried to remove the device through the jugular sheath, the balloon material was stuck at the sheath.As a result, the balloon catheter broke in half leaving the part of the catheter and the torn balloon pieces inside the patient.Subsequently, the physician punctured on the right femoral artery with a 16 french sheath.After angiography, a minor vessel injury was observed.The device was successfully removed by snare.The procedure was increased by three hours and was completed with another of same device.The patient was sent to emergency room for monitoring possible complications.It was further reported that the patient condition was stable post procedure.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16451945
• Report Number: 2124215-2023-08600
• Device Sequence Number: 17525476
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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): 04/27/2023

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: 11/14/2025
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0030541787
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 04/06/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/20/2023; 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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: 78 YR
• Patient Sex: Female