MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939135204010

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a coyote es balloon catheter in three pieces.There is blood in the inflation lumen.The shaft, hypotube, and bonds were microscopically and visually examined.There are numerous shaft kinks and the shaft is stretched in numerous locations.The midshaft is torn/broken 107.6cm from the hub.The shaft is stretched in numerous locations and severely kinked in numerous locations; therefore the measurement of the second shaft separation was not able to be obtained.The balloon is completely circumferentially torn.The distal end of the balloon, tip and distal markerband were not returned.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that difficulty removing and a shaft break occurred.The 100% stenosed target lesion was located in a moderately tortuous and severely calcified iliac vessel.A 2mmx40mmx145cm coyote¿ es balloon catheter was advanced for dilatation.However, upon delivering, the device became stuck and could not be removed.The physician then attempted to pull the device and the shaft detached.The device was surgically removed.No further patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter in three pieces.There is blood in the inflation lumen.The shaft, hypotube, and bonds were microscopically and visually examined.There are numerous shaft kinks and the shaft is stretched in numerous locations.The midshaft is torn/broken 107.6cm from the hub.The shaft is stretched in numerous locations and severely kinked in numerous locations; therefore the measurement of the second shaft separation was not able to be obtained.The balloon is completely circumferentially torn.The distal end of the balloon, tip and distal markerband were not returned.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that difficulty removing and a shaft break occurred.The 100% stenosed target lesion was located in a moderately tortuous and severely calcified iliac vessel.A 2mmx40mmx145cm coyote es balloon catheter was advanced for dilatation.However, upon delivering, the device became stuck and could not be removed.The physician then attempted to pull the device and the shaft detached.The device was surgically removed.No further patient complications were reported and the patient's status was good.

• Brand Name: COYOTE¿ ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7249267
• MDR Text Key: 99298490
• Report Number: 2134265-2018-00533
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: H74939135204010
• Device Catalogue Number: 39135-20401
• Device Lot Number: 0021475493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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
• Patient Outcome(s): Required Intervention