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

Model Number 7214

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date the incident occurred was estimate as 01-aug-2019 which is the first day of the month of the aware date.

Event Description

It was reported that shaft break and removal difficulties occurred.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during inflation at 24 atmospheres, the shaft broke.Removal difficulty was noted so an optical coherence tomography was performed to assess the situation.Finally, the wire and the balloon were completely removed by snaring.No patient complications were reported.

Manufacturer Narrative

B3 - date the incident occurred was estimate as (b)(6) 2019 which is the first day of the month of the aware date.Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 108cm distal of the strain relief at the midshaft bond.There was contrast and blood in the inflation lumen and contrast in the balloon.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that shaft break and removal difficulties occurred.A 2.50mm x 20mm nc emerge balloon catheter was advanced for dilation.However, during inflation at 24 atmospheres, the shaft broke.Removal difficulty was noted so an optical coherence tomography was performed to assess the situation.Finally, the wire and the balloon were completely removed by snaring.No patient complications were reported.

• Brand Name: NC 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: 8960176
• MDR Text Key: 156441440
• Report Number: 2134265-2019-10622
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (y/n): N
• PMA/PMN Number: K141236
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0023584574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention