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

Model Number	H7493895912250
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an apex balloon catheter with no other devices.The shaft, balloon and tip was microscopically examined.The inner shaft was buckled 1mm from the bi-component weld.The outer shaft had imprints 2.5cm from the bi-component weld.The tip was separated from the catheter and not returned for analysis.The end of the separation was jagged and stretched showing evidence of tensile overload.A test.014¿ guidewire was attempted to pass through the catheter, however, due to the buckled location the guidewire could not be advanced through the catheter.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 26-mar-2018.It was reported that difficulty loading wire occurred.During introduction of a 2.50mm x 12mm apex¿ balloon catheter into the wire, it would not come out the wire port or the wire lumen.Several more attempts were tried which caused the wire to be bent/kinked and the balloon would not go over the wire which caused the wire lumen to be damaged.The device was not used inside the patient and the procedure was completed with another wire and another of the same balloon catheter.No patient complications were reported.However, returned device analysis revealed tip detached/separated.

• 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: 7445167
• Report Number: 2134265-2018-03082
• Device Sequence Number: 1950183
• Product Code: LOX
• UDI-Device Identifier: 08714729475491
• UDI-Public: 08714729475491
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 03/26/2018

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: 09/18/2020
• Device Model Number: H7493895912250
• Device Catalogue Number: 38959-1225
• Device Lot Number: 21155281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1