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

Model Number	24674
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Foreign Body In Patient (2687)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment and un-retrieved device fragment occurred; the patient experienced perforation, blood loss, pain, and vomiting.Both groins were accessed and 5fr sheaths were inserted.The close to 100% stenosed, chronic totally occluded target lesion was located in the non-tortuous and severely calcified right iliac artery in the common-external iliac junction.A 6x60x135 mustang balloon catheter was first used to predilate the area and the balloon was removed without issue.A 8.0 x 60, 135cm mustang balloon catheter was then advanced for further dilatation and was held dilated for 30 seconds before it was deflated.The balloon was pulled out with intense care as to not obstruct the view of the area just treated and then took a subtracted run.A perforation then was detected.The physician re-advanced the same balloon back into position and re-inflated until the stent could be prepped for deployment.When the stent was prepped, the balloon was then deflated.However, during removal the device, the whole balloon came off the shaft.The wire along with the shaft came completely out of the body.The physician re-inserted the guidewire quickly and deployed two 8x59x135 and a 8x39x135 non-boston scientific (bsc) stents, which closed the perforation completely.The detached balloon material was left inside the patient and was trapped to the outer vessel wall by the deployment of stents.The procedure was completed with post-dilatation of a 9x60x75 mustang balloon catheter.The patient experienced pelvic and abdominal pain 8 out of 10, nausea, vomiting, blood loss, somewhat uncontrolled heart rate and blood pressure related to perforation.The patient was given 50mg of fentanyl to treat the pain.The patient was stable but was sent to intensive care unit for close observation.
Additional Manufacturer Narrative
Device evaluated by mfr.: the mustang 8.0 x 60, 135cm, was received for analysis.The device was received with the distal section of the device detached including a section of shaft, markerbands, tip and the entire balloon material.The detached distal section of the device was not returned for analysis.A visual examination found the shaft of the device to be completely detached at approximately 1410mm distal of the strain relief.The shaft also had severe stretching damage beginning at the detachment site and extending for approximately 300mm proximally.This type of damage is consistent with excessive tensile force being applied to the device.

• 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: 15437981
• Report Number: 2124215-2022-32679
• Device Sequence Number: 17561114
• Product Code: FGE
• UDI-Device Identifier: 08714729794714
• UDI-Public: 08714729794714
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 10/03/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028133567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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; Other; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White