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

Model Number H74939185252210

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a coyote balloon catheter with a stopcock attached to the hub.The balloon was loosely folded with blood in the hub, balloon, inflation lumen and wire lumen.The device was soaked in a warm waterbath for 5 days.The tip, balloon, markerband, inner/outer shaft (lumen) were microscopically, tactile and visually inspected.Inspection revealed a pinhole in the balloon material located 11.5cm proximally from the distal markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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

Reportable based on device analysis completed on 19-aug-2018.It was reported that crossing difficulties were encountered.The target lesion was located in a vessel below the knee.A 2.5mm x 220mm x 150cm coyote¿ balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a 2.0mm x 20mm x 150cm coyote¿ balloon catheter.No patient complications nor injuries were reported.However, returned device analysis revealed balloon pinhole.

• 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: 7876850
• MDR Text Key: 120395061
• Report Number: 2134265-2018-07430
• 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
• Report Date: 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: H74939185252210
• Device Catalogue Number: 39185-25221
• Device Lot Number: 0021514664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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