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

Model Number	7142
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left coronary artery.A 1.50mm x 12mm emerge otw balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient injuries reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left coronary artery.A 1.50mm x 12mm emerge otw balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient injuries reported, and the patient was stable post procedure.It was further reported that the 20% stenosed target lesion was located in the mildly tortuous marshall vein.The balloon was ruptured during the second inflation at 8 atmospheres for 15 seconds.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the loosely folded balloon.The was blood in the guidewire lumen.The balloon was found to have a pinhole 1mm proximal to the markerband.Product analysis confirmed the reported event, as the device was found to have a pinhole to the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left coronary artery.A 1.50mm x 12mm emerge otw balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient injuries reported, and the patient was stable post procedure.It was further reported that the 20% stenosed target lesion was located in the mildly tortuous marshall vein.The balloon was ruptured during the second inflation at 8 atmospheres for 15 seconds.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18093143
• Report Number: 2124215-2023-62115
• Device Sequence Number: 12218240
• Product Code: LOX
• UDI-Device Identifier: 08714729806684
• UDI-Public: 08714729806684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2024

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: 10/04/2024
• Device Model Number: 7142
• Device Catalogue Number: 7142
• Device Lot Number: 0030286059
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 12/21/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/23/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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 Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG