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

Model Number 7211

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

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 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
• 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: 15235677
• MDR Text Key: 297994442
• Report Number: 2124215-2022-29234
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846338
• UDI-Public: 08714729846338
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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 Outcome(s): Other; Required Intervention