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

Model Number	7518
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The patient presented with heart disease.The 90% stenosed target lesion was located in the calcified middle left anterior descending artery.A 1.50mm x 12mm apex flex balloon catheter was advanced for dilation.The physician used a runthrough, and was able to go right in with apex flex balloon catheter.The apex flex balloon catheter was inflated and ruptured on the first inflation.The device was removed with no issue.However, patient angiography revealed the balloon markers and a portion of the of the shaft was still inside the body.The physician tried for an hour to rewire the device but failed.Patient was not surgical candidate due to age and risk factors and snaring was not done, the family decided against it when given the option due to potential risk factors.After hours and many consultations with the extended physician team and patient family, the detached portion of the balloon was left in the body and the patient was put on anti-coagulation therapy.No further patient complications were reported.The patient was stable and was expected to be discharged and fully recover.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The patient presented with heart disease.The 90% stenosed target lesion was located in the calcified middle left anterior descending artery.A 1.50mm x 12mm apex flex balloon catheter was advanced for dilation.The physician used a runthrough, and was able to go right in with apex flex balloon catheter.The apex flex balloon catheter was inflated and ruptured on the first inflation.The device was removed with no issue.However, patient angiography revealed the balloon markers and a portion of the of the shaft was still inside the body.The physician tried for an hour to rewire the device but failed.Patient was not surgical candidate due to age and risk factors and snaring was not done, the family decided against it when given the option due to potential risk factors.After hours and many consultations with the extended physician team and patient family, the detached portion of the balloon was left in the body and the patient was put on anti-coagulation therapy.No further patient complications were reported.The patient was stable and was expected to be discharged and fully recover.It was further reported via medwatch mw5110892 that the balloon catheter was detached from the guidewire and remained in the patient's body with the balloon still inflated.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete device return of an apex balloon catheter, and a non-boston scientific (bsc) guidewire.Media was provided.The device was visually and microscopically examined.There were numerous kinks and bends to the hypotube of the device.The device was returned incomplete as there was full shaft detachment at the midshaft bond where the midshaft bond, inflation lumen, guidewire lumen, markerbands, balloon, and tip were not returned.The full length of the hypotube, at 123.9cm from the strain relief, was returned.The returned non-bsc guidewire was measured with a laser micrometer to measure the outer diameter which was within compatible use.Review of the media depicted an incomplete device of an apex balloon catheter with numerous kinks and bends visible.The hypotube portion of the device was visible and no shaft lumen or balloon was present confirming detachment, as well as aligning to what was found in analysis.Product analysis was able to confirm the reported detachment, as there was full shaft detachment of the shaft and the shaft portion and balloon failed to return for further analysis.Therefore, because the balloon failed to return, the burst was unable to be confirmed.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The patient presented with heart disease.The 90% stenosed target lesion was located in the calcified middle left anterior descending artery.A 1.50mm x 12mm apex flex balloon catheter was advanced for dilation.The physician used a runthrough, and was able to go right in with apex flex balloon catheter.The apex flex balloon catheter was inflated and ruptured on the first inflation.The device was removed with no issue.However, patient angiography revealed the balloon markers and a portion of the of the shaft was still inside the body.The physician tried for an hour to rewire the device but failed.Patient was not surgical candidate due to age and risk factors and snaring was not done, the family decided against it when given the option due to potential risk factors.After hours and many consultations with the extended physician team and patient family, the detached portion of the balloon was left in the body and the patient was put on anti-coagulation therapy.No further patient complications were reported.The patient was stable and was expected to be discharged and fully recover.It was further reported via medwatch mw5110892 that the balloon catheter was detached from the guidewire and remained in the patient's body with the balloon still inflated.

• Brand Name: APEX FLEX
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15113359
• Report Number: 2124215-2022-27164
• Device Sequence Number: 14890071
• Product Code: LOX
• UDI-Device Identifier: 08714729758464
• UDI-Public: 08714729758464
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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: 10/20/2024
• Device Model Number: 7518
• Device Catalogue Number: 7518
• Device Lot Number: 0028242516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/01/2022; 09/09/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/05/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female