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

Model Number 7163

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event.The date of the event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.

Event Description

It was reported that a shaft break and pain occurred.A percutaneous coronary intervention (pci) was performed on a calcified target lesion.A 3.50 x 15mm emerge balloon was advanced to the dilate the target lesion.While withdrawing the device, resistance was encountered, and the monorail part of the catheter broke.The broken monorail part (the distal area of the catheter) was removed with a trapper balloon and a guiding catheter.The patient was reported to have pain, but was fully okay after the catheter was removed.The procedure was completed with another of the same device and no further patient complications were reported in relation to this event.

Event Description

It was reported that a shaft break and pain occurred.A percutaneous coronary intervention (pci) was performed on a calcified target lesion.A 3.50 x 15mm emerge balloon was advanced to the dilate the target lesion.While withdrawing the device, resistance was encountered, and the monorail part of the catheter broke.The broken monorail part (the distal area of the catheter) was removed with a trapper balloon and a guiding catheter.The patient was reported to have pain, but was fully okay after the catheter was removed.The procedure was completed with another of the same device and no further patient complications were reported in relation to this event.

Manufacturer Narrative

B3: date of event.The date of the event is unknown.Bsc became aware of the event on (b)(6) 2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.H6 impact code updated to additional device required.Device evaluated by mfr: the returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks and a complete separation 24.5cm distal to the strain relief.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.

• 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: 10831079
• MDR Text Key: 215974820
• Report Number: 2134265-2020-15744
• 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
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0024783829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other