MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date.Event date not provided.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the cephalic arch.A 12-4/5.8/75 xxl vascular balloon catheter was advanced for dilatation.The balloon was inflated, deflated, and was pulled down to the mid fistula.However, upon trying to inflate the balloon again, the pressure would not increase and upon pulling back the syringe, blood was noticed which indicated that the balloon had ruptured.The device was pulled out from the sheath and entire device aside from the tip was not visible.The tip lodged in an aneurysm that was successfully retrieved by making an incision and pulling it out using a curved forceps.No further patient complications were reported.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of the bsc aware date.Event date not provided.Device evaluated by mfr.: the complaint device was returned for analysis.A visual examination identified a complete circumferential tear of the balloon material located approximately 10mm distal of the proximal sleeve of the balloon.The distal section of balloon material had been completely detached from the device at the distal balloon bond.This type of damage is consistent with excessive tensile force being applied to the device.The rate of burst pressure of this device is 8atm.A visual and tactile examination found the shaft to have been severely stretched/damaged between the proximal and distal balloon bonds.This type of damage is consistent with excessive tensile force being applied to the device.A visual and microscopic examination markerbands identified no issues with the markerbands.A visual and microscopic examination found no damage or issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the cephalic arch.A 12-4/5.8/75 xxl vascular balloon catheter was advanced for dilatation.The balloon was inflated, deflated, and was pulled down to the mid fistula.However, upon trying to inflate the balloon again, the pressure would not increase and upon pulling back the syringe, blood was noticed which indicated that the balloon had ruptured.The device was pulled out from the sheath and entire device aside from the tip was not visible.The tip lodged in an aneurysm that was successfully retrieved by making an incision and pulling it out using a curved forceps.No further patient complications were reported.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10514892
• Report Number: 2134265-2020-11817
• Device Sequence Number: 3539296
• Product Code: LIT
• UDI-Device Identifier: 08714729096146
• UDI-Public: 08714729096146
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K150303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 12/16/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0024945141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR