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

Model Number	24691
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.The patient underwent a vascular access interventional therapy.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified cephalic vein.A 0.014in guidewire was advanced into the vessel followed by a catheter.No resistance when advancing.A 4mm x 20mm x 144cm coyote es was selected for treatment.The device was inflated three times at 14 atmospheres and sheath imaging was performed.During the removal of the balloon, it got separated in the over-the-wire part.The patient went through an operation to remove the device and the catheter.No fragments were left inside.Cause of separation was unknown but implantation of non-boston scientific stent was not unsuccessful, so procedure was not completed due to this event.No insufficient condition during inflation was observed in the stent.There were no patient complications reported.
Event or Problem Description
It was reported that balloon detachment occurred.The patient underwent a vascular access interventional therapy.The 95% stenosed target lesion was located in the moderately tortuous and non-calcified cephalic vein.A 0.014in guidewire was advanced into the vessel followed by a catheter.No resistance when advancing.A 4mm x 20mm x 144cm coyote es was selected for treatment.The device was inflated three times at 14 atmospheres and sheath imaging was performed.During the removal of the balloon, it got separated in the over-the-wire part.The patient went through an operation to remove the device and the catheter.No fragments were left inside.Cause of separation was unknown but implantation of non-boston scientific stent was not unsuccessful, so procedure was not completed due to this event.No insufficient condition during inflation was observed in the stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks to the hypotube.The inflation lumen and guidewire lumen were separated approximately 24.5cm from the tip.Microscopic examination revealed that the inflation lumen and guidewire lumen is torn longitudinally from the exit notch to the separation.No other damages noted.

• Brand Name: COYOTE ES
• 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: 19514622
• Report Number: 2124215-2024-34771
• Device Sequence Number: 17002625
• Product Code: LIT
• UDI-Device Identifier: 08714729767299
• UDI-Public: 08714729767299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 02/08/2026
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0031016593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: COMMAND.; GUIDEWIRE: COMMAND.; INFLATION DEVICE: NIPRO.; INFLATION DEVICE: NIPRO.; INTRODUCER SHEATH: MOSQUITO.; INTRODUCER SHEATH: MOSQUITO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown