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

Model Number	7133
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed, 2mmx28mm was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for use.However, during the procedure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.At 52.5cm and 72.7cm from the strain relief, the hypotube of the device was kinked.The balloon was loosely folded.The device was attached to an inflation device filled with water and was inflated to rated burst pressure.The device inflated and deflated with no issue or irregularity.Product analysis could not confirm reported event as the device inflated to rated burst pressure and deflated with no issue.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed, 2mmx28mm was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for use.However, during the procedure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications nor injuries reported and the patient status was stable.

• 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: 13336738
• Report Number: 2134265-2022-00578
• Device Sequence Number: 3919099
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 03/26/2024
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0027755679
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 69 KG