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

Model Number H74939185201510

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that balloon deflation failure occurred.Vascular access was obtained via the left femoral artery utilizing a 6fr 50cm non-bsc introducer sheath.The (b)(4) stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 0.014x175 non-bsc guide wire has crossed the lesion, a 2.0mm x 150mm x 150cm coyote (tm) balloon catheter was used for pre-dilation.The balloon was inflated to 10 atmospheres and the device performed without issue.However, during attempt to deflate for 3 minutes, the balloon would not deflate.The pressure gauge on the inflation device showed "0".The balloon was retracted into the sheath slowly and was removed from the patient, (b)(4) deflated.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote balloon catheter.There was contrast in the balloon.Microscopic examination of distal shaft presented no irregularities that could have contributed to the damage.No distal weld damage was found.The balloon was loosely folded.Microscopic inspection found no damage or irregularities.Functional testing was performed by connecting an inflation device filled with water to the hub.The device was inflated with water to the rated burst pressure (rbp) for 5 minutes.The complaint device was made to deflate by applying negative pressure with the inflation device, and the device deflated in 26 seconds.Microscopic inspection of the markerbands and proximal weld found no irregularities or defects.Inspection of the remainder of the device revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that balloon deflation failure occurred.Vascular access was obtained via the left femoral artery utilizing a 6fr 50cm non-bsc introducer sheath.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 0.014x175 non-bsc guide wire has crossed the lesion, a 2.0mm x 150mm x 150cm coyote balloon catheter was used for pre-dilation.The balloon was inflated to 10 atmospheres and the device performed without issue.However, during attempt to deflate for 3 minutes, the balloon would not deflate.The pressure gauge on the inflation device showed "0." the balloon was retracted into the sheath slowly and was removed from the patient, 50% deflated.The procedure was completed with this device.No patient complications were reported and the patient's status was good.

• Brand Name: COYOTE¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5310385
• MDR Text Key: 33865111
• Report Number: 2134265-2015-08648
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/25/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H74939185201510
• Device Catalogue Number: 39185-20151
• Device Lot Number: 18373299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2015
• 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
• Treatment: GUIDEWIRE: CRUISE 0.014X17