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

Model Number	7135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The patient underwent percutaneous coronary intervention.The target lesion was located in a calcified right superficial femoral artery (sfa).A 3.50mm x 30mm emerge balloon catheter was advanced for dilatation.However, after the second inflation, the device broke in sfa.The device was retrieved using another guide.The procedure was completed successfully with no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was blood and contrast present within the inflation lumen and balloon.The balloon was loosely folded.At 25mm distal to the midshaft bond, the inflation lumen was twisted and stretched for a length of 1mm.At 12mm distal from the rapid port exchange (rpe), the shaft was separated.Running distally from the rpe for a length of 12mm, there was a longitudinal tear of the inflation lumen and guidewire lumen.At the rpe for a length of 3mm, the shaft was stretched.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent percutaneous coronary intervention.The target lesion was located in a calcified right superficial femoral artery (sfa).A 3.50mm x 30mm emerge balloon catheter was advanced for dilatation.However, after the second inflation, the device broke in sfa.The device was retrieved using another guide.The procedure was completed successfully with no patient complications nor injuries reported.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16513613
• Report Number: 2124215-2023-10790
• Device Sequence Number: 15012569
• Product Code: LOX
• UDI-Device Identifier: 08714729806455
• UDI-Public: 08714729806455
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/24/2023

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: 07/07/2024
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0028361894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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: Required Intervention
• Patient Sex: Unknown