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

Model Number	7213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used the first day of the month of the bsc aware date.Event date not provided.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the tortuous and moderately to severely calcified circumflex coronary artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during the first inflation at 14 atmospheres for 15 seconds, the balloon ruptured in the lesion.Subsequently, another 3.50mm x 15mm nc emerge balloon catheter was advanced for dilation; however, during the first inflation at 14 atmospheres for 15 seconds, it also ruptured.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported and the patient was fine.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of the bsc aware date.Event date not provided.Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The balloon was loosely folded, and there was blood in the balloon and inflation lumen.The device was soaked in a warm waterbath for 2 days.Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, and a pinhole leak in the balloon material located 3mm from the tip of the balloon.Inspection of the rest of the device found no other damage or defect.The reported rupture was confirmed.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device is 20 atmospheres (atm).The reported information indicates the device was inflated to 14atm; therefore, there is no indication the device was inflated over rbp.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the tortuous and moderately to severely calcified circumflex coronary artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during the first inflation at 14 atmospheres for 15 seconds, the balloon ruptured in the lesion.Subsequently, another 3.50mm x 15mm nc emerge balloon catheter was advanced for dilation; however, during the first inflation at 14 atmospheres for 15 seconds, it also ruptured.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported and the patient was fine.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9841294
• Report Number: 2134265-2020-02989
• Device Sequence Number: 11484681
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 11/21/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024814330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1