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	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter removal difficulty occurred.Vascular access was obtained by contralateral approach.The chronic totally occluded target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.After a 6f non-bsc sheath was in place and a non-bsc guidewire crossed the lesion, dilation was performed using a 3mm coyote balloon catheter and a 5.0 x 100, 135cm mustang balloon catheter was used for size up dilation.However, it was noted that the mustang balloon catheter was unable to remove.It seemed that it got caught in the y connector.Several attempts such as reinsertion and inflating repeatedly were performed, but failed.The device was removed together with the sheath and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: mustang device - 5x10x135cm was received for analysis.The device was received together with the customer's 6fr sheath and loaded on to the customer's guidewire.The recommended introducer/guide sheath size for this device is minimum 6fr sheath.The sheath used by the customer was a 6fr.During analysis the investigator applied negative pressure to the device and successfully advanced it through the customer's 6fr sheath and withdrew it with a little resistance experienced due to the balloon having been inflated and the presence of solidified blood.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 found no damage or kinks to the shaft of the device.A visual and microscopic examination identified no damage to the tip of the device.No issues were noted with the returned device that could potentially have contributed to the complaint.
Event or Problem Description
It was reported that catheter removal difficulty occurred.Vascular access was obtained by contralateral approach.The chronic totally occluded target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.After a 6f non-bsc sheath was in place and a non-bsc guidewire crossed the lesion, dilation was performed using a 3mm coyote balloon catheter and a 5.0 x 100, 135cm mustang balloon catheter was used for size up dilation.However, it was noted that the mustang balloon catheter was unable to remove.It seemed that it got caught in the y connector.Several attempts such as reinsertion and inflating repeatedly were performed, but failed.The device was removed together with the sheath and the procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 10499569
• Report Number: 2134265-2020-11394
• Device Sequence Number: 2961523
• Product Code: FGE
• UDI-Device Identifier: 08714729793533
• UDI-Public: 08714729793533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/08/2020

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: 08/01/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024207309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 035RADIFOCUS; GUIDEWIRE: 035RADIFOCUS; INTRODUCER SHEATH: TERUMO DESTINATION; INTRODUCER SHEATH: TERUMO DESTINATION