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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and patient anxiety occurred.The patient presented with angina.The target lesion was located in a coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke and the patient experienced anxiety.The detached portion of the device was pulled out of the body for removal, no intervention was required.The procedure was completed with a different device.No further complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete device return of an emerge mr balloon catheter.The device was visually and microscopically examined.There was a hypotube separation, however, the proximal portion of the hypotube as well as the manifold were not returned.The full length of the device returned was 78.7cm.The separated end was ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.
Event or Problem Description
It was reported that shaft break and patient anxiety occurred.The patient presented with angina.The target lesion was located in a coronary artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke and the patient experienced anxiety.The detached portion of the device was pulled out of the body for removal, no intervention was required.The procedure was completed with a different device.No further complications were reported and the patient was fully recovered.

• Brand Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13503433
• Report Number: 2134265-2022-00681
• Device Sequence Number: 17468686
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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): 04/13/2022

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: 08/06/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0028533603
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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
• Patient Sex: Unknown