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

Model Number	7211
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred requiring additional intervention.The patient was being treated for bifurcation lesion and underwent percutaneous coronary intervention.The target lesion was located in the moderately tortuous circumflex artery and ramus coronary artery.After placing stents at the bifurcation, a 5.00mm x 8mm nc emerge balloon catheter was used to perform the balloon kissing technique.However, when trying to withdraw the balloon from the ramus, the balloon adhered and became stuck to the stent strut and approximately 12-18 inches of the balloon shaft were left inside the patient.After several hours, the balloon was extracted after multiple attempts at snares.The procedure was completed and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete nc emerge mr balloon catheter.The device was visually and microscopically examined.There was blood in the hub of the device.There were numerous kinks to the hypotube of the device.At 2.7cm distal to the midshaft bond, the shaft was separated.The distal portion of the separation failed to return for further analysis of which would include the distal portion of the shaft (guidewire lumen and inflation lumen), the balloon, markerbands, and tip of the device.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred requiring additional intervention.The patient was being treated for bifurcation lesion and underwent percutaneous coronary intervention.The target lesion was located in the moderately tortuous circumflex artery and ramus coronary artery.After placing stents at the bifurcation, a 5.00mm x 8mm nc emerge balloon catheter was used to perform the balloon kissing technique.However, when trying to withdraw the balloon from the ramus, the balloon adhered and became stuck to the stent strut and approximately 12-18 inches of the balloon shaft were left inside the patient.After several hours, the balloon was extracted after multiple attempts at snares.The procedure was completed and there were no patient complications reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16939381
• Report Number: 2124215-2023-22279
• Device Sequence Number: 6017803
• Product Code: LOX
• UDI-Device Identifier: 08714729846321
• UDI-Public: 08714729846321
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2024
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0029967536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male