MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895912200
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that catheter removal difficulties were encountered and balloon detachment occurred.The target lesion was located in the heavily calcified carotid artery.After a non-bsc filter wire was unable to cross the lesion, a 2.00 mm x 12 mm apex¿ balloon catheter was advanced for dilation.However, after dilation was performed, when the physician went to pull the balloon out of the body, he was not able to retract it.Eventually, he was able to get the balloon shaft back.When fluoroscopy was performed, it was noted that the balloon marker was still in the carotid artery.The detached balloon was retrieved with a 10 mm snare.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
device evaluated by mfr: returned product consisted of an apex inner shaft that was stuck on an unidentified 0.14" guidewire.The shaft was microscopically examined.The inner shaft was buckled and stretched on the guidewire.A measurement could not be taken due to the condition of the device.The separated ends of the inner shaft are consistent with tensile overload.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that catheter removal difficulties were encountered and balloon detachment occurred.The target lesion was located in the heavily calcified carotid artery.After a non-bsc filter wire was unable to cross the lesion, a 2.00mm x 12mm apex balloon catheter was advanced for dilation.However, after dilation was performed, when the physician went to pull the balloon out of the body, he was not able to retract it.Eventually, he was able to get the balloon shaft back.When fluoroscopy was performed, it was noted that the balloon marker was still in the carotid artery.The detached balloon was retrieved with a 10mm snare.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7358334
• Report Number: 2134265-2018-02049
• Device Sequence Number: 2311732
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: 08714729475477
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/23/2018

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: 01/11/2021
• Device Model Number: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 21606828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/13/2018
• 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