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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: a mustang device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 17mm in length and extended from a position 18mm proximal of the distal markerband to 35mm proximal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
Reportable based on device analysis completed on 26-jul-2023.It was reported that balloon leak was encountered.The 70% stenosed long target lesion was located in mildly tortuous and moderately calcified right superficial femoral artery (sfa).A 30mg heparin sodium injection was applied via intravenous injection, and a 6f sheath was exchanged.A guidewire was used with vertebral artery catheter to cross right sfa and reach the popliteal artery.Distal angiography verified that the device was in the true lumen.Through the guidewire, balloons were advanced (4mmx80mm non-boston scientific and 5.0 x 100, 135cm mustang balloon catheters) to dilate part by part.However, during initial inflation, it was noted that the contrast was leaking from the balloon.The device was removed by pulling out.After replacing the balloon with another of same device and dilation was completed, an auto-expansive drug eluting bare 6mmx100mm stent was advanced and deployed at the target location.Then via guidewire a 5mmx 10mm mustang balloon catheter was advanced to dilate.Another angiography showed that right sfa blood flow was restored with rather high speed.There were no signs of embolization at the distal end.The procedure was completed.There were no patient complications nor injuries were reported.The patient status was stable.However, returned device analysis revealed that the balloon had longitudinal torn.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17442622
• Report Number: 2124215-2023-39618
• Device Sequence Number: 2531630
• Product Code: FGE
• UDI-Device Identifier: 08714729793533
• UDI-Public: 08714729793533
• 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
• Report Date (Section B): 08/02/2023

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: 06/28/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029675802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/02/2023
• Date Device Manufactured: 06/29/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG