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

Model Number	27775
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the visual inspection was noted the balloon was torn circumferentially at its proximal end; the balloon was not detached from the catheter, it only rolled to the distal tip of the catheter; the proximal and distal bonds are continuous.The distal tip of the catheter looked in good condition, its surface was smooth, indicating it was not broken.No more damages were found in the device.Functional testing cannot be performed based on the returned condition of the balloon.
Event or Problem Description
It was reported that the balloon was not present.The target lesion was located in inter iliac.A 7/2/100 occlusion balloon catheter was selected for use.During the procedure, the balloon was inserted through the non-bsc 7f introducer.However, when they inflated it and liquid flushed out, it was noted that the balloon was not present on the catheter.No fragments of the device were found, recovered and left inside the patient.The procedure was complete with different device.No problem noted from the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer:during the visual inspection was noted the balloon was torn circumferentially at its proximal end; the balloon was not detached from the catheter, it only rolled to the distal tip of the catheter; the proximal and distal bonds are continuous.The distal tip of the catheter looked in good condition, its surface was smooth, indicating it was not broken.No more damages were found in the device.Functional testing cannot be performed based on the returned condition of the balloon.
Event or Problem Description
It was reported that the balloon was not present.The target lesion was located in inter iliac.A 7/2/100 occlusion balloon catheter was selected for use.During the procedure, the balloon was inserted through the non-bsc 7f introducer.However, when they inflated it and liquid flushed out, it was noted that the balloon was not present on the catheter.No fragments of the device were found, recovered and left inside the patient.The procedure was complete with different device.No problem noted from the patient.

• Brand Name: OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8424934
• Report Number: 2134265-2019-02529
• Device Sequence Number: 2205517
• Product Code: MJN
• UDI-Device Identifier: 08714729112396
• UDI-Public: 08714729112396
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K132990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 07/23/2019
• Device Model Number: 27775
• Device Catalogue Number: 27775
• Device Lot Number: 0021767635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1