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

Model Number	7211
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment and removal difficulties were encountered.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified left main and proximal left anterior descending artery.The physician implanted a 4.0mm stent and a 5.00mm x 8mm nc emerge balloon catheter was used for post-dilatation.However, during deflation of balloon, resistance was felt in removing the balloon from the stent and multiple attempts were made to deflate the balloon to its smallest profile.The tip and proximal of the balloon was kinked and the balloon became stuck on the guidewire.After full deflation, the physician pulled the balloon very hard and the balloon was removed from the left main stent.The balloon and guidewire were removed together intact and the balloon catheter was noted to be shortened or wrinkled.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment and removal difficulties were encountered.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified left main and proximal left anterior descending artery.The physician implanted a 4.0mm stent and a 5.00mm x 8mm nc emerge balloon catheter was used for post-dilatation.However, during deflation of balloon, resistance was felt in removing the balloon from the stent and mulitple attempts were made to deflate the balloon to its smallest profile.The tip and proximal of the balloon was kinked and the balloon became stuck on the guidewire.After full deflation, the physician pulled the balloon very hard and the balloon was removed from the left main stent.The balloon and guidewire were removed together intact and the balloon catheter was noted to be shortened or wrinkled.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
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 was a complete separation at 48.9cm distal of the strain relief.There was no proximal portion of the device.There was contrast and blood in the inflation lumen and contrast in the balloon, and blood in the guidewire lumen.The balloon was loosely folded.The inner shaft was buckled 50mm from the tip.The outer shaft was severely stretched down.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported difficulty removing the device.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11725287
• Report Number: 2134265-2021-04906
• Device Sequence Number: 19833303
• Product Code: LOX
• UDI-Device Identifier: 08714729846321
• UDI-Public: 08714729846321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0026381945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1