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

Model Number	7142
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.At 96.8cm, and 98.4cm from the strain relief of the device, the shaft was kinked.At 4mm from the tip of the device, for a length of 12mm, the guidewire lumen and distal markerband were flattened.The folds of the balloon were tight however, they were manipulated open but have no signs of inflation.
Event or Problem Description
Reportable based on device analysis completed on 04-apr-2022.It was reported that shaft kink occurred.The 95% stenosed, 10x2.00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the delivery shaft was kinked.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed markerband damage.Returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.At 96.8cm, and 98.4cm from the strain relief of the device, the shaft was kinked.At 4mm from the tip of the device, for a length of 12mm, the guidewire lumen and distal markerband were flattened.The folds of the balloon were tight however, they were manipulated open but have no signs of inflation.Product analysis confirmed the reported event, as the shaft of the device was kinked.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14226814
• Report Number: 2134265-2022-04506
• Device Sequence Number: 5308843
• Product Code: LOX
• UDI-Device Identifier: 08714729806691
• UDI-Public: 08714729806691
• 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
• Report Date (Section B): 04/27/2022

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: 01/08/2023
• Device Model Number: 7142
• Device Catalogue Number: 7142
• Device Lot Number: 0026600697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 63 KG