MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7164

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2018

Event Type  malfunction  

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified right anterior interventricular artery.Pre-dilation was performed with a 2.50 mm x 20 mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190 cm samurai guidewire, resistance was felt again and then a thread approximately 15 cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified ight anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The emerge balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon is loose and there is blood present in the guidewire lumen.The foreign thread is not with the emerge catheter so further testing cannot be done.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the presence of a foreign thread.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified right anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The emerge balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon is loose and there is blood present in the guidewire lumen.The foreign thread is not with the emerge catheter so further testing cannot be done.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the presence of a foreign thread.

Manufacturer Narrative

Evaluation conclusion code has been changed from no problem detected 67 to adverse event related to procedure 4311.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/20/2018 03:47 pm ct.The report number is being corrected from: 2134265-2018-64601 to: 2134265-2018-61503.

Event Description

It was reported that foreign matter was found.The 90% stenosed target lesion was located in the highly calcified ight anterior interventricular artery.Pre-dilation was performed with a 2.50mm x 20mm emerge balloon catheter and a 24 x 2.75 promus premier select stent was successfully implanted.During the withdrawal of the stent delivery system there was resistance felt at the end of the non-bsc guide catheter.When the stent delivery system was pulled off the straight tip 190cm samurai guidewire, resistance was felt again and then a thread approximately 15cm long came out and was rolled up on the side and was described as looking like plastic.The procedure was completed and there was no harm to the patient.The emerge balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon is loose and there is blood present in the guidewire lumen.The foreign thread is not with the emerge catheter so further testing cannot be done.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the presence of a foreign thread.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7956287
• MDR Text Key: 123394364
• Report Number: 2134265-2018-61503
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: 7164
• Device Catalogue Number: 7164
• Device Lot Number: 0022331650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER; ABBOTT VISTA BRIGHT GUIDE CATHETER
• Patient Age: 52 YR