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

Model Number	H74939186400610
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coyote balloon leaked and was unable to be deflated.A coyote, 4.0mm x 60mm x 150cm, otw was selected for use to treat a case of in-stent restenosis in the right lower extremity.The target lesion was severely calcified and moderately tortuous with 100% stenosis.The first coyote balloon tracked well over the unknown 6fr pedal sheath.A ranger balloon was unable to track over the sheath, and was replaced with a sterling balloon, which tracked reasonably well.The second coyote balloon was advanced to the target lesion and inflated, and it was observed that the balloon was leaking.The coyote balloon was unable to be deflated, and the entire system was pulled from the pedal access.The procedure was cancelled, as the in-stent stenosis was deemed to be too extensive.There were no reported patient complications.
Event or Problem Description
It was reported that the coyote balloon leaked and was unable to be deflated.A coyote, 4.0mm x 60mm x 150cm, otw was selected for use to treat a case of in-stent restenosis in the right lower extremity.The target lesion was severely calcified and moderately tortuous with 100% stenosis.The first coyote balloon tracked well over the unknown 6fr pedal sheath.A ranger balloon was unable to track over the sheath, and was replaced with a sterling balloon, which tracked reasonably well.The second coyote balloon was advanced to the target lesion and inflated, and it was observed that the balloon was leaking.The coyote balloon was unable to be deflated, and the entire system was pulled from the pedal access.The procedure was cancelled, as the in-stent stenosis was deemed to be too extensive.There were no reported patient complications.It was further reported that the target lesion was located in the superficial femoral artery.The second coyote balloon was inflated to nominal pressure when the leak was observed.The coyote balloon was removed intact from the patient in a semi-deflated state over the course of 10-15 seconds by walking the balloon off the guidewire.Once removed from the patient, a pinhole rupture was noted on the balloon.
Event or Problem Description
It was reported that the coyote balloon leaked and was unable to be deflated.A coyote, 4.0mm x 60mm x 150cm, otw was selected for use to treat a case of in-stent restenosis in the right lower extremity.The target lesion was severely calcified and moderately tortuous with 100% stenosis.The first coyote balloon tracked well over the unknown 6fr pedal sheath.A ranger balloon was unable to track over the sheath, and was replaced with a sterling balloon, which tracked reasonably well.The second coyote balloon was advanced to the target lesion and inflated, and it was observed that the balloon was leaking.The coyote balloon was unable to be deflated, and the entire system was pulled from the pedal access.The procedure was cancelled, as the in-stent stenosis was deemed to be too extensive.There were no reported patient complications.It was further reported that the target lesion was located in the superficial femoral artery.The second coyote balloon was inflated to nominal pressure when the leak was observed.The coyote balloon was removed intact from the patient in a semi-deflated state over the course of 10-15 seconds by walking the balloon off the guidewire.Once removed from the patient, a pinhole rupture was noted on the balloon.
Additional Manufacturer Narrative
This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #.".

• 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: 18093639
• Report Number: 2124215-2023-62645
• Device Sequence Number: 12218247
• Product Code: DQY
• UDI-Device Identifier: 08714729796633
• UDI-Public: (01)08714729796633(17)20260425(10)0031498848
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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: 04/25/2026
• Device Model Number: H74939186400610
• Device Catalogue Number: 24704
• Device Lot Number: 0031498848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 07/09/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/06/2023; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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: COYOTE BALLOON DILATATION CATHETER; COYOTE BALLOON DILATATION CATHETER; COYOTE BALLOON DILATATION CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; STERLING BALLOON DILATATION CATHETER; STERLING BALLOON DILATATION CATHETER; STERLING BALLOON DILATATION CATHETER
• Patient Age: 65 YR
• Patient Sex: Male