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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered and a foreign material was found on the device.The target lesion was located in the iliac vein.The physician punctured the left femoral vein and placed 10f vascular sheath.After a 260cm hydrophilic guidewire crossed the inferior vena cava, the physician then advanced a catheter and replaced with a stiff hydrophilic guidewire.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.When the physician inflated the balloon, the balloon was seen inflated under digital subtraction angiography (dsa), however, contrast agent could not be filled into the balloon.The balloon was inflated at 14 atmospheres, but the balloon was not seen to inflate under dsa.The physician slightly bent the balloon delivery shaft and it was felt there was foreign body in the delivery shaft.The balloon could not be filled with contrast agent, and the pressure could not release as well.The balloon could not be removed from the patient.The physician cut the balloon delivery shaft, the pressure released, but the contrast agent could not flow out from the balloon.The physician gave pressure to the end of the cut delivery shaft that was connected to the pressure pump, and a green foreign body which was about 1.5cm long flowed out from the port.Subsequently, the physician used ultrasound and punctured skin.The balloon was punctured, and the contrast agent was withdrawn from the balloon using a syringe.The balloon was successfully removed.The procedure was completed with a 14x90 xxl boston scientific (bsc) balloon catheter and placed a14x90 and 16x90 bsc stents.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that removal difficulties were encountered and a foreign material was found on the device.The target lesion was located in the iliac vein.The physician punctured the left femoral vein and placed 10f vascular sheath.After a 260cm hydrophilic guidewire crossed the inferior vena cava, the physician then advanced a catheter and replaced with a stiff hydrophilic guidewire.A 12.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.When the physician inflated the balloon, the balloon was seen inflated under digital subtraction angiography (dsa), however, contrast agent could not be filled into the balloon.The balloon was inflated at 14 atmospheres, but the balloon was not seen to inflate under dsa.The physician slightly bent the balloon delivery shaft and it was felt there was foreign body in the delivery shaft.The balloon could not be filled with contrast agent, and the pressure could not release as well.The balloon could not be removed from the patient.The physician cut the balloon delivery shaft, the pressure released, but the contrast agent could not flow out from the balloon.The physician gave pressure to the end of the cut delivery shaft that was connected to the pressure pump, and a green foreign body which was about 1.5cm long flowed out from the port.Subsequently, the physician used ultrasound and punctured skin.The balloon was punctured, and the contrast agent was withdrawn from the balloon using a syringe.The balloon was successfully removed.The procedure was completed with a 14x90 xxl boston scientific (bsc) balloon catheter and placed a14x90 and 16x90 bsc stents.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 12.0 x 60, 135cm was received for analysis.The device was received in two sections due to a dissection of the shaft.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 24mm distal of the proximal markerband and extending approximately 4mm distally across the balloon material.It was stated in the complaint summary that balloon was manually punctured using a syringe to facilitate the removal of contrast media.No other issues were noted with the balloon material.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual examination found the shaft of the returned device to be separated at approximately 970mm distal of the strain relief.It was stated in the complaint summary that the shaft was manually dissected in an attempt to release pressure from the balloon.When carrying out a tactile examination of the shaft the investigator suspected the possibility of an obstruction within the shaft of the device.For investigation purposes the investigator dissected the shaft at approximately 10mm proximal of the proximal balloon sleeve.A visual examination of the inflation identified a foreign object within the inflation lumen of the device.The foreign object measuring approximately 280mm in length and green in colour was removed from the lumen of the device.No other issues were identified with the shaft of the device.A visual identified damage to the tip.This type of damage is consistent with the device encountering resistance when crossing the lesion.This concludes the product analysis.

• 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: 14959474
• Report Number: 2134265-2022-07331
• Device Sequence Number: 6896449
• Product Code: FGE
• UDI-Device Identifier: 08714729795018
• UDI-Public: 08714729795018
• 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
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026503007
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 53 KG