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

Model Number 7214

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in left anterior descending artery.A 3.75mm x 20mm nc emerge balloon catheter was advanced for dilatation.After balloon inflation, the physician attempted to remove the device.However, the device was stuck on the unknown guidewire.Both the balloon catheter and the wire were pulled as a unit.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that catheter entrapment occurred.The target lesion was located in left anterior descending artery.A 3.75mm x 20mm nc emerge balloon catheter was advanced for dilatation.After balloon inflation, the physician attempted to remove the device.However, the device was stuck on the unknown guidewire.Both the balloon catheter and the wire were pulled as a unit.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast present in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The guidewire lumen was buckled and prolapsed 46mm from the tip at 5mm in length.Product analysis confirmed the reported event as the guidewire lumen was buckled and prolapsed.The damage is likely consistent with an interaction with a guidewire and could cause difficulty advancing and the wire to freeze up within the device during use or removal.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14958108
• MDR Text Key: 303401784
• Report Number: 2134265-2022-07093
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846680
• UDI-Public: 08714729846680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028911662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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
• Patient Age: 49 YR
• Patient Sex: Male