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

Model Number	24706
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery.A 2.5mm x 220mm x 150cm, coyote balloon catheter was advanced for dilatation and inflated at 8 atmospheres for 120 seconds.However, balloon would not fully deflate.The physician attempted multiple times to deflate the balloon and used the deflation device to pull negative pressure resulting to only minimal deflation of the balloon.Also, attempted to use a 10cc syringe with negative pressure but still the balloon would not fully deflate the ratio was 40 contrast and 60 saline.Several attempts were made over a course of a minute.The physician then proceeded to just remove the balloon while still inflated.And upon removing it appeared to be deflated.The procedure was completed using the original device.No patient complications were 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 a kink to the guidewire lumen 22cm from the tip.Microscopic examination revealed no additional damages.Functional testing was performed by inflating the balloon to rated burst pressure then deflating it.The balloon was able to deflate with no issues.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that deflation failure occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery.A 2.5mm x 220mm x 150cm, coyote balloon catheter was advanced for dilatation and inflated at 8 atmospheres for 120 seconds.However, balloon would not fully deflate.The physician attempted multiple times to deflate the balloon and used the deflation device to pull negative pressure resulting to only minimal deflation of the balloon.Also, attempted to use a 10cc syringe with negative pressure but still the balloon would not fully deflate the ratio was 40 contrast and 60 saline.Several attempts were made over a course of a minute.The physician then proceeded to just remove the balloon while still inflated.And upon removing it appeared to be deflated.The procedure was completed using the original device.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: 12447129
• Report Number: 2134265-2021-10997
• Device Sequence Number: 19678754
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 05/25/2024
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0027384203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention