MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EQUALIZER; CATHETER, PERCUTANEOUS

Model Number	20280
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was a stent graft located in the moderately tortuous vessel in the abdominal aorta.A 27/7/2/65 equalizer balloon catheter was advanced for dilatation.However, during the third inflation for 80 seconds, the balloon ruptured.Upon device removal, it was noted that a quarter of the balloon part got separated.When the physician checked inside the sheath, the detached balloon material could not be found.Angiography was performed all the way to the peripheral and it was confirmed that there were no issue with the blood flow.The detached fragments of the balloon were not found.The procedure was completed with 17-107 equalizer balloon catheter.No further patient complcations were reported and the patient's status was good.
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was a stent graft located in the moderately tortuous vessel in the abdominal aorta.A 27/7/2/65 equalizer balloon catheter was advanced for dilatation.However, during the third inflation for 80 seconds, the balloon ruptured.Upon device removal, it was noted that a quarter of the balloon part got separated.When the physician checked inside the sheath, the detached balloon material could not be found.Angiography was performed all the way to the peripheral and it was confirmed that there were no issue with the blood flow.The detached fragments of the balloon were not found.The procedure was completed with 17-107 equalizer balloon catheter.No further patient complcations were reported and the patient's status was good.Device evaluated by manufacturer: equalizer unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The balloon was found burst/ruptured and a section of the balloon was detached and it was not returned.No other damages were found in the device.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7866001
• Report Number: 2134265-2018-60923
• Device Sequence Number: 19251988
• Product Code: MJN
• UDI-Device Identifier: 08714729402374
• UDI-Public: 08714729402374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140273
• 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): 10/03/2018

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: 09/24/2019
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0022030122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: RADIFOCUS AMPLATZ; GUIDEWIRE: RADIFOCUS AMPLATZ; INTRODUCER SHEATH: 16FR LT18FR; INTRODUCER SHEATH: 16FR LT18FR
• Outcome Attributed to Adverse Event: Other