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

Model Number	24705
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unsealed device packaging was encountered.A 2.0mm x 150mm x 150cm coyote balloon catheter was selected for use.However, upon opening the box to remove the balloon packaging, the balloon fell out due to unsealed packaging.The device was not used inside the patient and the procedure was completed with another balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote balloon catheter still in the shelf box.Media was provided by the customer in the form of a photo.Review of the photo shows that the bottom is not sealed.The condition of the pouch matched what was received for analysis.Visual examination revealed that the device pouch is not sealed on the bottom.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that unsealed device packaging was encountered.A 2.0mm x 150mm x 150cm coyote balloon catheter was selected for use.However, upon opening the box to remove the balloon packaging, the balloon fell out due to unsealed packaging.The device was not used inside the patient and the procedure was completed with another balloon catheter.No patient complications were reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12085055
• Report Number: 2134265-2021-08069
• Device Sequence Number: 11730012
• Product Code: DQY
• UDI-Device Identifier: 08714729796459
• UDI-Public: 08714729796459
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 11/18/2023
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0026381984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1