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

Model Number	7580
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft detachment occurred.This 2.50mm x 12mm maverick balloon catheter was selected for a percutaneous coronary intervention.During removal from the lesion difficulties were encountered and the distal end of the balloon became stuck inside the guide catheter and broke.If was noted that the balloon was deflated prior to removal.No patient complications were reported.
Event or Problem Description
It was reported that a shaft detachment occurred.This 2.50mm x 12mm maverick balloon catheter was selected for a percutaneous coronary intervention.During removal from the lesion difficulties were encountered and the distal end of the balloon became stuck inside the guide catheter and broke.If was noted that the balloon was deflated prior to removal.No patient complications were reported.It was further reported that the lesion was 90-99% stenosed, without a significant bend and located in the first marginal.The lesion was treated via shockwave treatment but the convey guide catheter was not stable so they selected this maverick balloon catheter which was put over another manufacturers guidewire for back up support.During withdrawal through the forearm significant resistance was met and the maverick became stuck inside the middle of the convery guide catheter, they attempted to remove the device by using another manufactures balloon catheter, without success.They removed all the devices from the patient, rinsed the guide catheter and the last piece of the maverick device was removed from the patient.The device was completely removed from the patient and the patient status is ok.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen and balloon.There was blood in the guidewire lumen, and the shaft had numerous kinks.27.5cm from the tip of the device, the shaft was separated.The ends of the separation were jagged indicating the shaft was torn.The inflation lumen on the proximal end of the separation was stretched down for a total length of 32.7cm.The shaft of the distal portion of the separation was stretched including both the inflation lumen and guidewire.The balloon was loosely folded.
Event or Problem Description
It was reported that a shaft detachment occurred.This 2.50mm x 12mm maverick balloon catheter was selected for a percutaneous coronary intervention.During removal from the lesion difficulties were encountered and the distal end of the balloon became stuck inside the guide catheter and broke.If was noted that the balloon was deflated prior to removal.No patient complications were reported.

• Brand Name: MAVERICK
• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12591886
• Report Number: 2134265-2021-12584
• Device Sequence Number: 19905952
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P860019
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0026631942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 12/14/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/21/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown