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

Model Number	H7493912415300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right circumflex artery.A 3.00x15mm nc quantum apex mr balloon catheter was advanced through guidewire without difficulty.Before the device entered into the patient, the shaft broke into two pieces.The procedure was completed with another balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, tip, shaft, and hypotube were microscopically and tactile inspected.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Microscopic examination and tactile inspection revealed numerous kinks throughout the hypotube and shaft.There was a complete hypotube separation 23.5 cm from the end of the strain relief.The hypotube fracture surfaces were oval, which suggests the device was kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, 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 is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right circumflex artery.A 3.00 x 15 mm nc quantum apex mr balloon catheter was advanced through guidewire without difficulty.Before the device entered into the patient, the shaft broke into two pieces.The procedure was completed with another balloon catheter.No patient complications were reported.

• Brand Name: NC QUANTUM 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: 6515620
• Report Number: 2134265-2017-03989
• Device Sequence Number: 1641442
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: (01)08714729783374(17)20200229(10)20338032
• Combination Product (Y/N): N
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 02/29/2020
• Device Model Number: H7493912415300
• Device Catalogue Number: 39124-1530
• Device Lot Number: 20338032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1