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

Model Number	20280
Medical Device Problem Codes	Deflation Problem (1149); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon deflation issue occurred.A 33/7/2/100mm equalizer balloon catheter was advanced and inflated for dilatation.However, the balloon could not be deflated despite several attempts using a syringe.Subsequently, negative pressure was applied several times but the balloon still failed to deflate.After a while, negative pressure was again applied and the balloon was deflated.The procedure was completed and no patient complications reported.The physician noted that it seemed the inflation lumen got blocked.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: unit returned with its original box, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The balloon was carefully inspected and it did not show visual defects, it was in good condition.No more damages were found in the returned device.The balloon was inflated and no issues was noted.Also, the balloon was able to deflate without issues.No occlusion was noted.
Event or Problem Description
It was reported that balloon deflation issue occurred.A 33/7/2/100mm equalizer balloon catheter was advanced and inflated for dilatation.However, the balloon could not be deflated despite several attempts using a syringe.Subsequently, negative pressure was applied several times but the balloon still failed to deflate.After a while, negative pressure was again applied and the balloon was deflated.The procedure was completed and no patient complications reported.The physician noted that it seemed the inflation lumen got blocked.

• Brand Name: EQUALIZER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10363379
• Report Number: 2134265-2020-10431
• Device Sequence Number: 19487296
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: 08714729402404
• 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): 09/23/2020

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: 10/05/2021
• Device Model Number: 20280
• Device Catalogue Number: 20280
• Device Lot Number: 0025490660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1