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

Model Number	24704
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that balloon rupture occurred.The 70% stenosed target was located in the mildly tortuous, and moderately calcified vessel below the knee.A 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at nominal pressure in less than a minute, the balloon ruptured.The device was removed successfully from the patient's body.And the procedure was completed with different device, with no patient complications were reported.
Additional Manufacturer Narrative
Returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the inflation lumen and guidewire lumen 45mm from the tip.Microscopic examination revealed a hole in the inflation lumen 107mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a hole in the inflation lumen.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target was located in the mildly tortuous and moderately calcified vessel below the knee.A 2.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the initial inflation at nominal pressure in less than a minute, the balloon ruptured.The device was removed successfully from the patient's body and the procedure was completed with different device with no patient complications were reported.

• 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: 17168039
• Report Number: 2124215-2023-30820
• Device Sequence Number: 15254145
• Product Code: DQY
• UDI-Device Identifier: 08714729797135
• UDI-Public: 08714729797135
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 01/26/2026
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0030935763
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian