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

Model Number	7132
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entrapment occurred.The target lesion was located in the non-calcified and non-tortuous left circumflex (lcx) artery extending into the first obtuse marginal branch.There was angulation into the lcx.After a samurai guide wire, along with another wire, was placed, a 2.50 mm x 12 mm emerge balloon catheter was advanced on the samurai.When the balloon was in the guide catheter, it got stuck on the samurai wire.It was noted that the wires were not crossed but the balloon got stuck midway in the guide.The emerge balloon and samurai wire remained intact and were removed together.There was no visible damage to the emerge balloon catheter.The procedure was completed with different devices and there were no patient complications.
Event or Problem Description
It was reported that entrapment occurred.The target lesion was located in the non-calcified and non-tortuous left circumflex (lcx) artery extending into the first obtuse marginal branch.There was angulation into the lcx.After a samurai guide wire, along with another wire, was placed, a 2.50 mm x 12 mm emerge balloon catheter was advanced on the samurai.When the balloon was in the guide catheter, it got stuck on the samurai wire.It was noted that the wires were not crossed but the balloon got stuck midway in the guide.The emerge balloon and samurai wire remained intact and were removed together.There was no visible damage to the emerge balloon catheter.The procedure was completed with different devices and there were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to both the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon was tightly folded.At the distal end of the rapid port exchange, the shaft was separated.On the most distal end of the proximal portion of the separation, for a length of 4mm, the inflation lumen was stretched.At the proximal end of the rapid port exchange, the shaft was stretched.From the bicomponent weld to just proximal from the tip of the device, the shaft was buckled and stretched.There was tip damage to the device.Product analysis confirmed the reported event as there was separation, stretching and buckling to the shaft of the device.

• 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: 17980651
• Report Number: 2124215-2023-58476
• Device Sequence Number: 16757698
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 03/25/2026
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0032078746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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