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

Model Number	H7493895812250
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the radiopaque markerbands were not visible under fluoroscopy.The target lesion was located in the diagonal branch of the left anterior descending (lad) artery.A 2.50mm x 12mm apex balloon catheter was advanced for dilation.However upon inserting the contrast isovue 370 with 100% contrast ratio, the two radiopaque markerbands were not visible and there was a difficulty in tracking over the wire.Several flushes and guidewire wipes were done and the device re-advanced for several times but it was unable to track over the wire.The device was eventually removed from the patient's body completely.The procedure was completed with a 2.50mmx8mm apex balloon catheter.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the apex balloon catheter.The shafts, balloon, markerbands, bonds, and tip were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Microscopic examination of the device revealed that the 11.5cm of the distal shaft was flattened and damaged proximal of the balloon bond.The tip was damaged.Both markerbands were present.The guidewire used in the procedure was not returned for analysis, so functional testing was performed using a test.014¿ guidewire.The guidewire was inserted into both the exit notch and tip however, the wire would not advance back the flattened shaft either way.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the direction for use states: ¿prepare the catheter for purging.Fill a luer lock syringe with contrast medium to inflate the balloon.Use only appropriate balloon inflation medium (e.G., the equivalent of a 50:50 mixture of contrast medium and sterile saline).Do not use air or any gaseous medium to inflate the balloon catheter.¿; however, it was reported that the contrast ratio used was 100%.(b)(4).
Event or Problem Description
It was reported that the radiopaque markerbands were not visible under fluoroscopy.The target lesion was located in the diagonal branch of the left anterior descending (lad) artery.A 2.50mm x 12mm apex¿ balloon catheter was advanced for dilation.However upon inserting the contrast isovue 370 with 100% contrast ratio, the two radiopaque markerbands were not visible and there was a difficulty in tracking over the wire.Several flushes and guidewire wipes were done and the device re-advanced for several times but it was unable to track over the wire.The device was eventually removed from the patient's body completely.The procedure was completed with a 2.50mmx8mm apex¿ balloon catheter.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: 6711903
• Report Number: 2134265-2017-07093
• Device Sequence Number: 1490542
• Product Code: LOX
• UDI-Device Identifier: 08714729474883
• UDI-Public: (01)08714729474883(17)20170831(10)18288842
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/26/2017

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: 08/31/2017
• Device Model Number: H7493895812250
• Device Catalogue Number: 38958-1225
• Device Lot Number: 18288842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR