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

Model Number 24699

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.After a non-bsc guide wire crossed the lesion, a 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation but it failed to cross.A 1.5mm x 20mm x 143cm coyote es balloon catheter was then advanced but it ruptured at first inflation.It was replaced with another 1.5mm x 20mm x 143cm coyote es balloon catheter which was able to dilate the lesion.Subsequently, dilation was again performed using the same 2.0mm x 220mm x 150cm coyote balloon catheter but the balloon ruptured on the first inflation.Another 2.0mm x 220mm x 150cm coyote balloon catheter was advanced; however, it also ruptured on the first inflation.The devices were completely removed, the physician used a 2mm x 40mm non-bsc balloon catheter to complete the procedure.No patient complications were reported and the patient's condition was stable.

• Brand Name: COYOTE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7824318
• MDR Text Key: 118537893
• Report Number: 2134265-2018-60503
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729796817
• UDI-Public: 08714729796817
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0021926797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1