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

Model Number	24673
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties and balloon dislodgement occurred.The target lesion was located in the inferior femoral artery.A 4.0 x 200, 135cm mustang balloon catheter was advanced for dilation.However, when the physician released the pressure after dilation, the balloon could not be withdrawn.Eventually, the physician removed the balloon, and the sheath and noticed that the balloon was dislodged.The dislodged balloon was simply pulled out and removed from the patient's body.The physician decided not to proceed ,and aborted the procedure.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang device 4x20x135cm was received for analysis.The device was received in two sections as a result of a complete break of the shaft.Both sections of the device were returned with the customer's guidewire advanced through them.The proximal section of the device was received advanced through the customer's 5fr sheath.As per mustang specification the recommended sheath size for this device is a minimum of 5fr.A visual and tactile examination found the shaft of the device to be severely stretched at more than one location.The shaft was also completely detached at approximately 400mm proximal of the proximal balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination identified that the balloon had been inflated.Due to the damage to the device a balloon leak test could not be carried out.No issue was observed with the markerbands or tip of the device that may have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties and balloon dislodgement occurred.The target lesion was located in the inferior femoral artery.A 4.0 x 200, 135cm mustang balloon catheter was advanced for dilation.However, when the physician released the pressure after dilation, the balloon could not be withdrawn.Eventually, the physician removed the balloon and the sheath and noticed that the balloon was dislodged.The dislodged balloon was simply pulled out and removed from the patient's body.The physician decided not to proceed and aborted the procedure.There were no patient complications reported and the patient's status was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10571287
• Report Number: 2134265-2020-12269
• Device Sequence Number: 3569312
• Product Code: LIT
• UDI-Device Identifier: 08714729793595
• UDI-Public: 08714729793595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 12/04/2022
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0024882737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70