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

Model Number H7493926712300

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

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There is tip damage. The hypotube shaft was completely separated 41. 5cm from the hub. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. There were numerous hypotube and shaft kinks. Reviews of documentation to ensure that all required in-process and final inspections and testing were completed and all acceptance criteria were met. There is no evidence that the device failed to meet applicable product specifications prior to shipment. 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. During preparation of a 3. 00mm x 12mm nc emerge balloon catheter, when the physician pulled the device out of the hoop, the catheter separated at the connection between the hypotube and distal catheter bond. The device never entered the patient's body and the procedure was completed with another of the same device. No patient complications were reported.

Manufacturer Narrative

(b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.   (b)(4).

Event Description

It was reported that shaft break occurred. During preparation of a 3. 00mm x 12mm nc emerge® balloon catheter, when the physician pulled the device out of the hoop, the catheter separated at the connection between the hypotube and distal catheter bond. The device never entered the patient's body and the procedure was completed with another of the same device. No patient complications were reported.

• 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: 6835949
• MDR Text Key: 246656224
• Report Number: 2134265-2017-08773
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/25/2019
• Device Model Number: H7493926712300
• Device Catalogue Number: 39267-1230
• Device Lot Number: 20927186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial