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

Model Number	24674
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.Vascular access was obtained via the left brachial artery.The stenosed target lesion was located in the left iliofemoral artery.After a 6f puncture sheath and a 6f non-bsc long sheath was placed, an 8.0 x 100, 135cm mustang balloon catheter was advanced for pre-dilation.However, following deflation, the balloon could not be retrieved even after several attempts.Subsequently, the balloon was forced back to the sheath and retrieved both devices.An 8x80 innova stent was implanted and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that removal difficulties were encountered.Vascular access was obtained via the left brachial artery.The stenosed target lesion was located in the left iliofemoral artery.After a 6f puncture sheath and a 6f non-bsc long sheath was placed, an 8.0 x 100, 135cm mustang balloon catheter was advanced for pre-dilation.However, following deflation, the balloon could not be retrieved even after several attempts.Subsequently, the balloon was forced back to the sheath and retrieved both devices.An 8x80 innova stent was implanted and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang device - 8x10x135cm was returned for analysis.The recommended introducer/guide sheath size for this device as per mustang is minimum 6fr sheath.The sheath used by the customer was not returned for analysis.During analysis the investigator applied negative pressure to the device and successfully advanced it through a boston scientific 6fr sheath and withdrew it with a little resistance experienced due to the balloon having been inflated.A visual examination identified that the balloon was subjected to positive pressure.No issues were identified with the balloon material which could potentially have contributed to this complaint.A visual and tactile examination the shaft of the device to be severely stretched at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination identified no damage to the tip of the device.

• 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: 10164227
• Report Number: 2134265-2020-07288
• Device Sequence Number: 19433039
• Product Code: FGE
• UDI-Device Identifier: 08714729794233
• UDI-Public: 08714729794233
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• 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): 07/16/2020

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: 12/08/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024901996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 55