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

Model Number	7141
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 23-nov-2022.It was reported that inflation failure occurred.The moderately stenosed target lesion was located in the moderately tortuous and severely calcified middle left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.The balloon was inflated third times with 5 seconds each inflation, however, the balloon failed to inflate.The procedure was completed with another of the same device.There were no patient complications reported and the patient is stable.However, returned device analysis revealed a balloon longitudinal torn.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge over the wire balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded.At 4mm from the tip of the device, there was a 2mm longitudinal tear to the balloon.Product analysis confirmed the reported event, as the balloon had a longitudinal tear.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15915530
• Report Number: 2124215-2022-50500
• Device Sequence Number: 6535792
• Product Code: LOX
• UDI-Device Identifier: 08714729807094
• UDI-Public: 08714729807094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: 12/14/2022
• Device Model Number: 7141
• Device Catalogue Number: 7141
• Device Lot Number: 0026512353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 52 KG