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	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in severely tortuous aorta-iliac.During the procedure, an equalizer 33/7/2/100 balloon catheter was advanced for dilatation.After the stent graft was placed, touch-up was performed without a problem from the aorta to the leg from the left side femoral.Next, after dilation was performed, when touch-up was performed from the right side femoral with the use of the same balloon, negative pressure was applied, but deflation could not be performed.The 20cc syringe was changed to 10cc syringe in first inflation and was able to perform the deflation slowly for four to five minutes manually and saline contrast ratio was approximately 50:50.This was attempted three times using the same size, 33mm, and 27mm all had the same issue.Eventually, touch-up was performed using gores coda balloon and was able to deflate with no resistance felt.The cause was not confirmed since the blood vessel was relatively straight anatomically.Moreover, there should be no resistance felt since the sheath was for stent graft and the lumen was thick.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in severely tortuous aorta-iliac.During the procedure, an equalizer 33/7/2/100 balloon catheter was advanced for dilatation.After the stent graft was placed, touch-up was performed without a problem from the aorta to the leg from the left side femoral.Next, after dilation was performed, when touch-up was performed from the right side femoral with the use of the same balloon, negative pressure was applied, but deflation could not be performed.The 20cc syringe was changed to 10cc syringe in first inflation and was able to perform the deflation slowly for four to five minutes manually and saline contrast ratio was approximately 50:50.This was attempted three times using the same size, 33mm, and 27mm all had the same issue.Eventually, touch-up was performed using gores coda balloon and was able to deflate with no resistance felt.The cause was not confirmed since the blood vessel was relatively straight anatomically.Moreover, there should be no resistance felt since the sheath was for stent graft and the lumen was thick.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1: initial reporter city - (b)(4).Device evaluated by mfr.: the device was retruned for analysis.The balloon was carefully inspected and it did not show visual defects, it was in good condition.The balloon was inflated and no issues were noted.Also, the balloon was able to deflate without issues.No more damages were found in the returned 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: 9865325
• Report Number: 2134265-2020-03686
• Device Sequence Number: 3268156
• 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): 04/23/2020

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: 03/08/2021
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0024552389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: 12F INTRODUCER SHEATH; 12F INTRODUCER SHEATH; MEDICOS HIRATA EGOISTGUIDEWIRE; MEDICOS HIRATA EGOISTGUIDEWIRE; MEDTRONIC ENDURANT STENT; MEDTRONIC ENDURANT STENT; 12F INTRODUCER SHEATH; MEDICOS HIRATA EGOISTGUIDEWIRE; MEDTRONIC ENDURANT STENT