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

Model Number H74939186302210

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Occlusion (1984)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported via facility medwatch# (b)(4) that radiopaque markerbands were not visible under fluoroscopy and vessel occlusion occurred.In (b)(6) 2016, the patient had a percutaneous transluminal angioplasty.The target lesion was located in the right posterior tibial artery.A 25.5cm sheath was introduced to the right posterior artery then a 3.0mmx 220mmx150cm was advanced for dilation.Without the physician's awareness, this caused occlusion of the artery which was not evident due to the sheath not being radiopaque and also its color being clear.The procedure was completed under fluoroscopic guidance.Twenty-two days later, the patient had an amputation below the knee of the right leg.The patient was recently discharged from the hospital.No further patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that an angiogram was obtained which demonstrated occlusion of the distal posterior tibial artery.It was concluded the patient either had a clot or a spasm of the posterior tibial artery.Furthermore, the balloon protector was introduced into the artery without the physician¿s awareness and was found in the lesion when the patient had a right below the knee amputation.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6088338
• MDR Text Key: 59451796
• Report Number: 2134265-2016-09748
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939186302210
• Device Catalogue Number: 39186-30221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other