MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24699
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A contralateral approach was performed to treat the stenotic and calcified right superficial femoral artery (sfa).The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right sfa.A 6fr sheath was inserted from the left femoral region, the guidewire crossed through the entire lesion part with a micro-catheter as a backup, and the lesion part was observed with intravascular ultrasound.A 4.0mm x 220mm x 150cm, coyote balloon catheter was advanced for pre-dilation.However, the lesion was partly calcified, and the indeflator gauge began to drop when the pressure was increased up to 8atm for 30 seconds.As further pressurization was no longer possible, the pressure was reduced, blood was drawn with plunger, and it was determined that the device has ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications reported and patient condition was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 82mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.A contralateral approach was performed to treat the stenotic and calcified right superficial femoral artery (sfa).The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right sfa.A 6fr sheath was inserted from the left femoral region, the guidewire crossed through the entire lesion part with a micro-catheter as a backup, and the lesion part was observed with intravascular ultrasound.A 4.0mm x 220mm x 150cm, coyote balloon catheter was advanced for pre-dilation.However, the lesion was partly calcified, and the indeflator gauge began to drop when the pressure was increased up to 8atm for 30 seconds.As further pressurization was no longer possible, the pressure was reduced, blood was drawn with plunger, and it was determined that the device has ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications reported and patient condition was good.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 17593407
• Report Number: 2124215-2023-44828
• Device Sequence Number: 15675019
• Product Code: DQY
• UDI-Device Identifier: 08714729796404
• UDI-Public: 08714729796404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111295
• 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
• Report Date (Section B): 10/05/2023

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: 03/02/2026
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0031161041
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: JUPITER FC; GUIDEWIRE: JUPITER FC; INFLATION DEVICE: GM30; INFLATION DEVICE: GM30; INTRODUCER SHEATH: DESTINATION 6FR; INTRODUCER SHEATH: DESTINATION 6FR; MICRO CATHETER: ZIZAI; MICRO CATHETER: ZIZAI
• Patient Sex: Male