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

Model Number H7493912415400

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter in two pieces.The balloon was loosely folded and there was blood in the lumen.The balloon, markerbands, proximal weld, and shaft were microscopically inspected.Inspection revealed numerous kinks in the hypotube, with the device separating at the distal edge of the port/exit notch.The separation is consistent with excessive tensile force.The port/exit notch was also revealed to have damage (stretched and perforation).Functional testing could not be done, due to the condition of the returned device.Microscopic inspection found the remainder of the device free of damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 22-aug-2016.It was reported that prepping difficulties were encountered.A 15mmx4.00mm nc quantum apex¿ balloon catheter was advanced for dilatation; however the catheter kept pulling air while it was inside the patient.The catheter was re-primed; however the air was stuck inside the catheter tubing.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed shaft break.

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5960642
• MDR Text Key: 55098765
• Report Number: 2134265-2016-08135
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: H7493912415400
• Device Catalogue Number: 39124-1540
• Device Lot Number: 19231921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1