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

Model Number	7132
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, while trying to cross the lesion, the shaft broke near the level of the touhy outside the patient's body.The remaining proximal shaft was removed over the wire and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used the first date of the month of the bsc aware date as no information was provided.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, while trying to cross the lesion, the shaft broke outside the patients body near the level of the touchy.The proximal remaining shaft was removed in normal fashion over the wire.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3-date of event: used the first date of the month of the bsc aware date as no information was provided.Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.At 45cm from the strain relief, the hypotube of the device was kinked.There was a separation of the hypotube 47.7cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.At 1.5cm distal to the separation, the hypotube was kinked.There was contrast in the inflation lumen, and the balloon was tightly folded.There was blood and contrast in the balloon folds.Product analysis confirmed the reported break as there was separation to the device.

• 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: 13845734
• Report Number: 2134265-2022-03156
• Device Sequence Number: 11944935
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/11/2022

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: 06/05/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0028172634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2021
• 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
• Patient Sex: Unknown