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

Model Number	20280
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the moderately tortuous and mildly calcified aorta.A 27/7/2/100 equalizer balloon catheter was advanced and inflated for dilatation.However, upon deflation, the balloon depressurized but could not be deflated.The device was pulled inside the sheath and was removed.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit was returned with its original box.The returned device matches with upn provided by the customer.The balloon was carefully inspected and it did not show visual defects, it was in good condition.The catheter of the device was carefully inspected and no damages were found.The balloon was inflated, also deflated during the 25 second according to directions for use without problems.No issues were noted with volumes.There were no leaks, holes or pin holes noted and the balloon was able to hold the pressure.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the moderately tortuous and mildly calcified aorta.A 27/7/2/100 equalizer balloon catheter was advanced and inflated for dilatation.However, upon deflation, the balloon depressurized but could not be deflated.The device was pulled inside the sheath and was removed.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9196788
• Report Number: 2134265-2019-12518
• Device Sequence Number: 3058008
• Product Code: MJN
• UDI-Device Identifier: 08714729402381
• UDI-Public: 08714729402381
• 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): 11/18/2019

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: 06/22/2020
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0023219779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/03/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1