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

Model Number	7518
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detach and unretrieved device fragment lead to additional surgery occurred.The 70% stenosed target lesion was located in the circumflex artery.A 2.50mm x 12mm apex balloon catheter was advanced for dilation.However, during third inflation at 14 atmospheres, the balloon ruptured.Physician again attempted to pull the balloon out.At that time the balloon portion detached from the shaft of the device.The shaft was successful removed but the actual balloon portion remained stuck in the coronary artery.Patient is scheduled to undergo bypass surgery.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an incomplete device return of an apex balloon catheter.The device was visually and microscopically examined.There was blood in the manifold of the device.There were numerous hypotube kinks.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 20cm from the rapid port exchange there was a separation of the guidewire lumen.At approximately 11mm distal from the proximal cone transition, there was circumferential tear in the balloon.There was an incomplete device return as a partial guidewire lumen, markerbands, tip, and the distal portion of the balloon failed to return.The device was visually and microscopically examined.There was blood in the manifold of the device.There were numerous hypotube kinks.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 20cm from the rapid port exchange there was a separation of the guidewire lumen.At approximately 11mm distal from the proximal cone transition, there was circumferential tear in the balloon.There was an incomplete device return as a partial guidewire lumen, markerbands, tip, and the distal portion of the balloon failed to return.
Event or Problem Description
It was reported that balloon detach and unretrieved device fragment lead to additional surgery occurred.The 70% stenosed target lesion was located in the circumflex artery.A 2.50mm x 12mm apex balloon catheter was advanced for dilation.However, during third inflation at 14 atmospheres, the balloon ruptured.Physician again attempted to pull the balloon out.At that time the balloon portion detached from the shaft of the device.The shaft was successfully removed but the actual balloon portion remained stuck in the coronary artery.Patient is scheduled to undergo bypass surgery.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13175869
• Report Number: 2134265-2021-16489
• Device Sequence Number: 17283770
• Product Code: LOX
• UDI-Device Identifier: 08714729475491
• UDI-Public: 08714729475491
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 07/06/2024
• Device Model Number: 7518
• Device Catalogue Number: 7518
• Device Lot Number: 0027619858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG