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

Model Number	7134
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in left anterior descending.A 3.00mm x 20mm emerge balloon catheter was advanced for pre-dilatation of an in-stent lesion.However, during removal, it was noticed that the balloon was detached from the shaft of the system.The balloon material was still intact.The procedure was completed with no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.Microscopic examination revealed the majority of the balloon had a longitudinal tear.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.However, the majority of the balloon was torn which could be perceived as a balloon detachment.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in left anterior descending.A 3.00mm x 20mm emerge balloon catheter was advanced for pre-dilatation of an in-stent lesion.However, during removal, it was noticed that the balloon was detached from the shaft of the system.The balloon material was still intact.The procedure was completed with no patient complications reported.

• Brand Name: 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: 9637493
• Report Number: 2134265-2020-00585
• Device Sequence Number: 501555
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 07/11/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0024767277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR