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

Model Number	7211
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon issues occurred requiring additional intervention to resolve.The target lesion was located in the mildly tortuous and mildly calcified left main/ left anterior descending artery.A 5.50mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, there was trouble in deflating and retracting the device.Eventually, the shaft was removed but the balloon was detached and remained on the guidewire.An attempt was made to buddy wiring and pin the piece with another balloon, but it was unsuccessful.A guidezilla guide extension catheter was then advanced over the proximal portion of the balloon to trap the balloon inside it.At some point during the case, the guidewire on which the broken balloon remained was removed and the balloon remained floating freely inside patient.The physician decided to pin the balloon permanently against the vessel wall with a synergy drug-eluting stent and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Returned product consisted of an incomplete nc emerge balloon catheter.The device was microscopically and visually examined.There were numerous hypotube and kinks to the device.There was separation of the inflation lumen at 13.7cm from the midshaft bond, which is also the length of the stretched shaft.The full length of the hypotube was returned.The rapid port exchange, distal inflation lumen, full guidewire lumen, markerbands, balloon and tip were not returned for analysis.There was contrast and blood in the inflation lumen.Product analysis could not confirm the reported deflation difficulties, as the balloon was not returned for analysis.However, given the damage to the device, the separation and removal difficulties were confirmed through the analysis as the inflation lumen was separated and the unretrievable fragments of the device indicate procedural and removal difficulties.B5 describe event or problem: corrected.
Event or Problem Description
It was reported that balloon issues occurred requiring additional intervention to resolve.The target lesion was located in the mildly tortuous and mildly calcified left main/ left anterior descending artery.A 5.50mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, there was trouble in deflating and retracting the device.Eventually, the shaft was removed but the balloon was detached and remained on the guidewire.An attempt was made to buddy wiring and pin the piece with another balloon, but it was unsuccessful.A guidezilla guide extension catheter was then advanced over the proximal portion of the balloon to trap the balloon inside it.At some point during the case, the guidewire on which the broken balloon remained was removed and the balloon remained floating freely inside patient.The physician decided to pin the balloon permanently against the vessel wall with a synergy drug-eluting stent and the procedure was completed.No patient complications were reported.It was also reported that the balloon was pulled negative and double negative.The balloon remained in the patient and appeared deflated.The patient did not experience any symptoms and was stable post procedure.

• 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
• 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: 15235677
• Report Number: 2124215-2022-29234
• Device Sequence Number: 4900194
• Product Code: LOX
• UDI-Device Identifier: 08714729846338
• UDI-Public: 08714729846338
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 11/17/2023
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0028400504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown