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

Model Number	7133
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The target lesion was located in the mildly tortuous and totally occluded right coronary artery.A 2.00 mm x 15 mm emerge was advanced to the lesion site and successfully inflated at 12 atm for 8 seconds.After full deflation and removal of the device from the body, the balloon was noted to be stuck on the non-boston scientific guidewire.The physician tried to forcefully remove the balloon from the guidewire and the shaft detached from the balloon.The guidewire was cut in order to remove the device and the balloon was described as severely mangled.A microcatheter and additional wire were advanced and the procedure was completed successfully with no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.Returned product consisted of an incomplete emerge mr balloon catheter and a non-bsc guidewire.The incomplete device fragments were visually and microscopically examined.At approximately 10cm in length was the combined total length of the returned portion of the device.There was contrast in the inflation lumen and the balloon which was loosely folded.At 5.2cm in length, the inflation lumen segment was returned kinked and flattened with no indicator as what portion this device would have been located.At 3cm in length, the shaft segment (inflation and guidewire lumen) was punctured, stretched down, and froze on a segment of the guidewire.At 2.5cm in length, the balloon contains a full circumferential tear.There are also two partial circumferential tears approximately 8mm proximal from distal waist.The balloon portion segment contained a froze wire segment of which the coil had unraveled.The tip and markerbands were present to the balloon segment.From the proximal markerband to the tip of the device, the tip and guidewire lumen were buckled.The non-bsc guidewire was shipped with the returned device, to which the wire segments were stuck and not moveable from the balloon.An outer diameter measurement to the guidewire was not performed due to the severity of damage to the device.The coil to the returned guidewire segments were stretched and unraveled.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The target lesion was located in the mildly tortuous and totally occluded right coronary artery.A 2.00 mm x 15 mm emerge was advanced to the lesion site and successfully inflated at 12 atm for 8 seconds.After full deflation and removal of the device from the body, the balloon was noted to be stuck on the non-boston scientific guidewire.The physician tried to forcefully remove the balloon from the guidewire and the shaft detached from the balloon.The guidewire was cut in order to remove the device and the balloon was described as severely mangled.A microcatheter and additional wire were advanced and the procedure was completed successfully with no patient complications.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18124830
• Report Number: 2124215-2023-62135
• Device Sequence Number: 15401296
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/04/2024

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: 05/13/2026
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0032395509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• Patient Sex: Unknown