MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927608200

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.The balloon was loosely folded with blood in the guide wire lumen (shaft) and the inflation lumen (shaft).The tip, balloon, markerbands, and shafts were microscopically and tactile inspected.Inspection revealed numerous kinks in the shafts, and a pinhole in the balloon material located over the distal markerband.Inspection of the remainder of the device revealed no other damage or irregularities.Although it was reported that the device was not used inside the patient, the presence of blood and in the guidewire and inflation lumens is indicative of handling beyond simply unpackaging the device, as was reported.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 03-april-2018.It was reported that shaft kink occurred.During preparation of a 2.00mm x 8mm nc emerge® balloon catheter, it was noted that the shaft was kinked.The procedure was completed with a different size non-bsc balloon catheter.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.

• Brand Name: NC EMERGE®
• 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: 7469996
• MDR Text Key: 106797823
• Report Number: 2134265-2018-03592
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: H7493927608200
• Device Catalogue Number: 39276-0820
• Device Lot Number: 20197029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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