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

Model Number	7134
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and removal difficulties were reported.A percutaneous coronary intervention was being performed.The target lesion was located in the mildly tortuous and severely calcified mid right coronary artery (rca).A 3.00mm x 20mm emerge balloon catheter was advanced for dilation.However, after athrectomy procedure, the balloon was stuck.It was attempted to re-inflate and deflate with a guide catheter but failed to retrieve the balloon.It was noted that the catheter was aggressively pulled, breaking the balloon and leaving a part in the rca.It was decided to leave the part in the patients body as no further complications were reported and the patients status was stable.
Event or Problem Description
It was reported that shaft break and removal difficulties were reported.The target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).A 3.00mm x 20mm emerge balloon catheter was advanced for dilation.However, after athrectomy procedure, the balloon was stuck.It was attempted to re-inflate and deflate with a guide catheter but failed to retrieve the balloon.It was noted that the catheter was aggressively pulled, breaking the balloon and leaving a part in the rca.It was decided to leave the part in the patient's body as no further complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
The returned product consisted of an incomplete device of an emerge mr balloon catheter.The distal portion not limited to the balloon and tip, was not returned with the remaining device.The device was returned with box packaging belonging to a different batch/lot number.The device was microscopically and visually examined.With the manifold present and at 3mm from the strain relief, the hypotube was separated.The separated ends were oval in shape indicating the device was kinked prior to separation.There were numerous hypotube kinks.There was no guidewire lumen present upon device return.The length of the returned inflation lumen that had presence of blood was 7.1 cm from the midshaft bond (moving distally).The inflation lumen was separated from the distal end of the device and the separation was of jagged edge indicating the inflation lumen was torn.Inspection of the remainder cannot be performed as it is an incomplete device return.Product analysis confirmed the reported break as there was separation to the device.The reported removal difficulties were confirmed as the inflation lumen was torn and separated indicating there were difficulties in the process of removal.

• 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: 12044855
• Report Number: 2134265-2021-07990
• Device Sequence Number: 897791
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 11/19/2023
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0027023934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/02/2021
• 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: Other