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

Model Number	7133
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon was stuck on a 0.014 non-boston scientific guidewire.The balloon could not be removed from the wire once outside the patient and had to used wire cutter to cut off the wire.The procedure was completed with another balloon catheter and no patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during the procedure, the balloon was stuck on a 0.014 non-boston scientific guidewire.The balloon could not be removed from the wire once outside the patient and had to used wire cutter to cut off the wire.The procedure was completed with another balloon catheter and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter and a non-bsc guidewire.The device was visually and microscopically examined.A stopcock was attached to the device upon return, with a non-bsc guidewire froze within the lumen of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The folds of the balloon were present, but they appear manipulated loose with no sign of inflation.At 10.8cm from the tip running proximal for a length of 3mm, the inflation lumen and guidewire lumen were buckled.At 6.4cm from the tip running proximal for a length of 1mm, the inflation lumen and guidewire lumen were buckled.At 2mm from the tip of the device, the distal waist of the balloon was detached, and at 15mm from the tip, the proximal waist of the balloon was detached.The movement of the detached balloon over the shaft was approximately 8cm from the tip of the device which indicates force of the device likely due to an attempt to remove the wire or an attempt to further advance the device during use.For a length of 24mm proximal to the tip of the device, the guidewire lumen was severely buckled, and the tip of the device was damaged.A laser micrometer was used to measure the outer diameter of the non-bsc guidewire returned within the balloon catheter.The exposed and undamaged portion of the wire was 0.0135 inch which is of compatible with the emerge.There is no visible sign of tampering or cutting of the wire.Product analysis confirmed the reported event as there was no movement of the returned wire within the device.There was also a balloon detachment, tip damage, buckling of the guidewire lumen and inflation lumen.

• 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: 15218308
• Report Number: 2124215-2022-30193
• Device Sequence Number: 6672848
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/29/2022

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: 12/20/2024
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0029279888
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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
• Patient Sex: Unknown