MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7518
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon removal difficulties were encountered.Vascular access was obtained via radial approach.The target lesion was located in the moderately tortuous and calcified coronary artery.A 2.50mm x 12mm apex balloon catheter was advanced for dilatation.However, upon withdrawal, the balloon could not be removed after it was inflated.Subsequently, a 0.35 stabilizing guide wire advanced and was used to remove the device.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was functionally tested with a.014" guidewire.No issues were detected inflating or deflating the balloon, or with advancing the device on a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon removal difficulties were encountered.Vascular access was obtained via radial approach.The target lesion was located in the moderately tortuous and calcified coronary artery.A 2.50mm x 12mm apex balloon catheter was advanced for dilatation.However, upon withdrawal, the balloon could not be removed after it was inflated.Subsequently, a 0.35 stabilizing guide wire advanced and was used to remove the device.There were no patient complications reported and the patient was fine.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9014480
• Report Number: 2134265-2019-10994
• Device Sequence Number: 2451766
• Product Code: LOX
• UDI-Device Identifier: 08714729475491
• UDI-Public: 08714729475491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 06/30/2022
• Device Model Number: 7518
• Device Catalogue Number: 7518
• Device Lot Number: 0024037097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR