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

Model Number	7133
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the patient died.In (b)(6) 2021, an index procedure was performed and implanted two synergy xd drug-eluting stents (des) and two synergy megatron des in the ostial left main artery (lm), ostial to proximal circumflex artery (cx), mid left anterior descending artery (lad), and ostial to proximal first diagonal artery (diag1).A chronic total occlusion was documented in the right coronary artery (rca).In (b)(6) 2022, the physician attempted to treat the restenosis found in the ostial cx.It was believed that the stents implanted in the ostial cx and lm were not fully expanded during the index procedure which led to the unintentional passing of guidewires through these unopposed stent struts.A 2.00 x 15mm emerge balloon catheter was advanced to the lm and into the cx where it was inflated to 10 atmospheres (atm), but the balloon ruptured.The physician attempted to remove the 2.00 x 15mm emerge but a significant resistance was encountered.The balloon got stuck in the vessel and when an extreme force was applied to remove the device, the distal half of the balloon fractured and remained stuck in the lm and cx.In order to trap and recover the distal shaft of the fractured device, a 2.00 x 15mm nc emerge balloon catheter was advanced into the lad and inflated to 16 atm.While withdrawing the inflated nc emerge balloon which was initially dragging the detached component of emerge balloon, the distal shaft of the nc emerge also fractured and was stuck in the lad.A non-bsc catheter-based miniaturized ventricular assist device was inserted to stabilize the patient but failed to sustain.Subsequently, the patient expired.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15837835
• Report Number: 2124215-2022-47843
• Device Sequence Number: 14752584
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 04/26/2025
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0030020841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male