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

Model Number	24698
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The greater than 90% stenosed target lesion was located in the mildly tortuous and severely calcified vessel below the knee.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres for 2 minutes, the balloon ruptured.The device was completely removed and there were no fragments left inside patient's body.The procedure was completed via alternative method.There were no patient complications reported.
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 circumferential tear 11.2cm 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.The greater than 90% stenosed target lesion was located in the mildly tortuous and severely calcified vessel below the knee.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres for 2 minutes, the balloon ruptured.The device was completely removed and there were no fragments left inside patient's body.The procedure was completed via alternative method.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The greater than 90% stenosed target lesion was located in the mildly tortuous and severely calcified vessel below the knee.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres for 2 minutes, the balloon ruptured.The device was completely removed and there were no fragments left inside patient's body.The procedure was completed via alternative method.There were no patient complications 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16502866
• Report Number: 2124215-2023-10799
• Device Sequence Number: 17716644
• Product Code: LIT
• UDI-Device Identifier: 08714729796886
• UDI-Public: 08714729796886
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2023

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: 09/26/2024
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0028095316
• 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: 03/04/2023
• Supplement Date Received by Manufacturer: 03/20/2023; 06/13/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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: 68 YR
• Patient Sex: Male