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

Model Number	7211
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch# (b)(4) that tip detachment occurred.The target lesion was located in the right radial artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation.However, after the balloon was inflated with high pressure, the tip of the balloon broke off in the right radial artery.The patient had to go to the operating room for an open procedure to remove the broken piece of balloon.The broken tip was found using fluoroscopy and was easily removed.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to b5 describe event or problem.It was initially reported that the target lesion was located in the right radial artery and the procedure was completed with a different device.The event was corrected.The target lesion is unknown and it was not indicated that the procedure was completed with a different device.
Event or Problem Description
It was reported via facility medwatch# (b)(4) that tip detachment occurred.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation.However, after the balloon was inflated with high pressure, the tip of the balloon broke off in the right radial artery.The patient had to go to the operating room for an open procedure to remove the broken piece of balloon.The broken tip was found using fluoroscopy and was easily removed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete device return of an nc emerge balloon catheter with a non-bsc guidewire.The device was visually and microscopically examined.The guidewire was received inside the device without movement upon device return.It was not able to be removed without further damaging the device.There was blood and contrast in the manifold and inflation lumen.Just distal to the rapid port exchange (rpe) the shaft was stretched down for a length of 3mm.At 4.4cm distal to the rpe, there was a puncture hole in the inflation lumen due to the hypotube jetting out of the shaft.For a length of 19cm, distal from the stretched down shaft to the end of the device, the shaft was severely buckled which included both the guidewire lumen and the inflation lumen.There was a shaft separation at the end of the buckled shaft segment.The balloon, markerbands, and tip failed to return for analysis.The guidewire returned was frozen within the device due to the severe buckling of the guidewire lumen, and the stretched down shaft.There was damage to the guidewire coils as they were separated and not level.This damaged area on the guidewire could have also been were the balloon would have been positioned, however, this could not be confirmed as the clinical circumstances could not be replicated.
Event or Problem Description
It was reported via facility medwatch# (b)(4) that tip detachment occurred.The target lesion was located in the right radial artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation.However, after the balloon was inflated with high pressure, the tip of the balloon broke off in the right radial artery.The patient had to go to the operating room for an open procedure to remove the broken piece of balloon.The broken tip was found using fluoroscopy and was easily removed.The procedure was completed with a different device.There were no patient complications reported.The event was corrected.The target lesion is unknown and it was not indicated that the procedure was completed with a different 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
• 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: 13307097
• Report Number: 2134265-2022-00401
• Device Sequence Number: 12006532
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2022

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: 11/03/2023
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0028317304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/07/2022; 07/14/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 03/08/2022; 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White