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

Model Number	7213
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty was encountered.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified circumflex artery.During a bifurcation kissing balloon technique of the first obtuse marginal and circumflex arteries, a 2.75mm x 15mm nc emerge balloon catheter became stuck in the circumflex artery.Attempts were made to remove the balloon; however, the patient was sent to surgery to have the balloon removed.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the returned device is in 5 pieces.The pieces are 123.3cm, 29.72cm, 20.1cm, 5cm, and 7.8cm long.The distal marker band and the tip is missing.There are multiple kinks along the hypotube.The inflation lumen is stretched and kink in multiple locations.Some of the separations are clean cut and some are jagged.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage consistent with difficulties withdrawing the device.
Event or Problem Description
It was reported that removal difficulty was encountered.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified circumflex artery.During a bifurcation kissing balloon technique of the first obtuse marginal and circumflex arteries, a 2.75mm x 15mm nc emerge balloon catheter became stuck in the circumflex artery.Attempts were made to remove the balloon; however, the patient was sent to surgery to have the balloon removed.No patient complications were 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: 9597859
• Report Number: 2134265-2020-00157
• Device Sequence Number: 3461164
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: 08714729846512
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 09/22/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024472985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention