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

Model Number	H7493896008150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an apex otw device and an unidentified guide wire loaded inside the lumen.The devices were bloody.The guide wire was measured and was found to be.0135¿.There was 178cm of guide wire sticking out of the hub and 27mm out of the tip.The tip, balloon, markerbands, shaft and hub was microscopically and tactile inspected.Inspection revealed buckling of the shaft located inside the hub with additional shaft damage (buckling) located 7mm from the tip of the device, and tip damage.Functional testing found that while the guide wire moved slightly in the apex device, the devices could not be separated.The damage with the device is consistent with excessive tensile force applied to the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 01-may-2018.A 1.50mm x 8mm apex¿ push balloon catheter was received with no reported issues.However, upon functional testing of the device with a guide wire, the devices could not be separated.

• Brand Name: APEX¿ PUSH
• 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: 7546087
• Report Number: 2134265-2018-04534
• Device Sequence Number: 19162070
• Product Code: LOX
• UDI-Device Identifier: 08714729475965
• UDI-Public: 08714729475965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 07/31/2018
• Device Model Number: H7493896008150
• Device Catalogue Number: 38960-0815
• Device Lot Number: 19510626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1