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

Model Number	7508
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used the first day of the month of aware date as no event date was provided.
Event or Problem Description
It was reported that catheter entrapment occurred.A 1.50mm x 20mm apex flex balloon catheter was advanced for dilatation.However, the balloon was unable to be advanced nor pull back from the wire.Both balloon and guidewire were removed from patient's body as a unit.No patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.A 1.50mm x 20mm apex flex balloon catheter was advanced for dilatation.However, the balloon was unable to be advanced nor pull back from the wire.Both balloon and guidewire were removed from patient's body as a unit.No patient complications were reported.
Additional Manufacturer Narrative
Used the first day of the month of aware date as no event date was provided.Device evaluated by mfr.:returned product consisted of an apex balloon catheter with a non-bsc 0.014 inch guidewire in the lumen.The hub, shafts, tip, and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The balloon was tightly folded.Inspection of the device revealed that the wire lumen shaft was buckled in the hub of the device with the wire lumen wavy for 18cm distal of the hub.The outer shaft was stretched 97cm distal of the hub to the proximal end of the balloon.A measurement of the shaft was not able to be performed with the shaft being stretched.The guidewire used in the procedure was received stuck inside the complaint device.An attempt to remove the guidewire was unsuccessful, as it was stuck on wire due to the buckled and stretched wire lumen shaft.The damage to the wire lumen shaft is consistent to damage caused by the guidewire during advancement or removal.

• 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
• MDR Report Key: 9678487
• Report Number: 2134265-2020-00948
• Device Sequence Number: 14119345
• Product Code: LOX
• UDI-Device Identifier: 08714729475095
• UDI-Public: 08714729475095
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/03/2020

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: 01/15/2021
• Device Model Number: 7508
• Device Catalogue Number: 7508
• Device Lot Number: 0023195619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: COMMAND ES; GUIDE WIRE: COMMAND ES