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

Model Number	7141
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire occurred.The 24mm x 3.5mm, 90% stenosed target lesion was located in mildly tortuous and moderately calcified right coronary artery.A 2.50mm x 8mm emerge balloon catheter was advanced for dilatation.However, the device was entrapped with the non-boston scientific guidewire and could not be withdrawn.Eventually, both devices withdrawn together.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that froze on wire occurred.The 24mm x 3.5mm, 90% stenosed target lesion was located in mildly tortuous and moderately calcified right coronary artery.A 2.50mm x 8mm emerge balloon catheter was advanced for dilatation.However, the device was entrapped with the non-boston scientific guidewire and could not be withdrawn.Eventually, both devices withdrawn together.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device/media analysis: the complaint device was not received for analysis.One photograph was attached and was reviewed and found to depict emerge device which matches the complaint batch number.The device issue mentioned in the complaint is not depicted in the photo and is deemed not applicable.H3 other text : photo review.
Event or Problem Description
It was reported that froze on wire occurred.The 24mm x 3.5mm, 90% stenosed target lesion was located in mildly tortuous and moderately calcified right coronary artery.A 2.50mm x 8mm emerge balloon catheter was advanced for dilatation.However, the device was entrapped with the non-boston scientific guidewire and could not be withdrawn.Eventually, both devices withdrawn together.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an emerge otw balloon catheter.There was contrast present in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 2mm, 5mm, and 7mm from the bicomponent weld for a length of 1mm each, the guidewire lumen was buckled.At 9cm for 2mm in length, and 7.1cm for 3mm in length, from the bicomponent weld, the shaft was buckled which included both the inflation lumen and the guidewire lumen.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through the tip of the device and encountered no difficulties.Photo media was reviewed and found to have two shaft segments that were visibly buckled.No further damage was detected from the media provided; however, the media aligns with some of the damages found in analysis.Product analysis could not confirm the reported event as the test guidewire was able to pass through the device without resistance or issue.The shaft of the device was buckled in numerous segments and this damage is most consistent with an interaction with a guidewire and could cause difficulty advancing and the wire to freeze up within the device during procedural use or due to an interaction with patient characteristics.

• 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: 15379149
• Report Number: 2124215-2022-32995
• Device Sequence Number: 20210215
• Product Code: LOX
• UDI-Device Identifier: 08714729807131
• UDI-Public: 08714729807131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2022

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: 08/17/2023
• Device Model Number: 7141
• Device Catalogue Number: 7141
• Device Lot Number: 0027850870
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 11/03/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/30/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG