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

Model Number 7213

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/31/2019

Event Type  Injury  

Event Description

It was reported that removal difficulty was encountered.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified circumflex artery.During a bifurcation kissing balloon technique of the first obtuse marginal and circumflex arteries, a 2.75mm x 15mm nc emerge balloon catheter became stuck in the circumflex artery.Attempts were made to remove the balloon; however, the patient was sent to surgery to have the balloon removed.No patient complications were reported and the patient was fine.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the returned device is in 5 pieces.The pieces are 123.3cm, 29.72cm, 20.1cm, 5cm, and 7.8cm long.The distal marker band and the tip is missing.There are multiple kinks along the hypotube.The inflation lumen is stretched and kink in multiple locations.Some of the separations are clean cut and some are jagged.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage consistent with difficulties withdrawing the device.

Event Description

It was reported that removal difficulty was encountered.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified circumflex artery.During a bifurcation kissing balloon technique of the first obtuse marginal and circumflex arteries, a 2.75mm x 15mm nc emerge balloon catheter became stuck in the circumflex artery.Attempts were made to remove the balloon; however, the patient was sent to surgery to have the balloon removed.No patient complications were reported and the patient was fine.

• 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: 9597859
• MDR Text Key: 175908539
• Report Number: 2134265-2020-00157
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024472985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention