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

Model Number H7493918915150

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

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break occurred.During preparation of a 1.50mm x 15mm emerge¿ balloon catheter, it was noted that the shaft was fractured.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of an emerge balloon catheter and a stopcock.The balloon was tightly folded with contrast in the inflation lumen.The tip, balloon, hypotube, inner and outer shafts were microscopically and tactile examined.Inspection revealed numerous kinks in the hypotube with a separation at 85.5 cm from the tip of the device.The end of the separation was oval, as if kinked prior to separation.Inspection of the remainder of the device revealed no other damage or irregularities.The presence of contrast/fluid in the inflation, indicates use of the device beyond preparation.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.Bsc id: (b)(4).Tw: 4875893.

Event Description

It was reported that shaft break occurred.During preparation of a 1.50mm x 15mm emerge¿ balloon catheter, it was noted that the shaft was fractured.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: 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: 7099913
• MDR Text Key: 94879627
• Report Number: 2134265-2017-11820
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121196
• 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,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: H7493918915150
• Device Catalogue Number: 39189-1515
• Device Lot Number: 20139364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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