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

Model Number H7493912415250

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.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

It was reported that shaft break occurred.A15mmx2.50mm nc quantum apex¿ balloon catheter was selected for use.During preparation, after flushing the balloon catheter, the device was loaded on the guidewire.No difficulties were encountered during loading.However, the shaft was broken 29cm from the hub.The device never entered the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a partial nc quantum apex balloon catheter.Only the hub, strain relief and part of the hypotube were returned for analysis.The hypotube was microscopically and tactile inspected.Inspection revealed a separation in the hypotube, located 78 cm from the strain relief.The end of the hypotube was oval, as if kinked prior to separation.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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that shaft break occurred.A15mmx2.50mm nc quantum apex¿ balloon catheter was selected for use.During preparation, after flushing the balloon catheter, the device was loaded on the guidewire.No difficulties were encountered during loading.However, the shaft was broken 29cm from the hub.The device never entered the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6043117
• MDR Text Key: 57927746
• Report Number: 2134265-2016-09162
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: H7493912415250
• Device Catalogue Number: 39124-1525
• Device Lot Number: 19509944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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