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

Model Number H74939186251510

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

Same case as mdr id: 2134265-2017-08067.It was reported that catheter entrapment and shaft break occurred.Patient presented with chronic obstructive arterial disease with claudication on movement and was hospitalized.The chronic obstructed target lesion was located in the right below the knee vessel.A 300mm choice¿ guide wire was advanced to the lesion.A 2.5mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced and dilated the lesion.A small remnant of stenosis was noted and the physician decided to perform additional dilatation.The coyote¿ balloon catheter was re-advanced however; when passing over the guide wire it was noted that it got stuck 140mm from the distal tip of the catheter which does not allow the device to be advanced or withdrawn.When trying to remove the coyote¿ balloon, the shaft broke.The guide wire and the balloon were completely removed from the patient.The wire and the balloon was able to be separated outside the patient's body.The procedure was completed with another of the same device.No patient complications reported, the patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned device consisted of a coyote balloon catheter only.The balloon was loosely folded with blood in the wire lumen, fluid in the balloon and inflation lumen.The tip, balloon, markerbands, proximal bond, inner and outer shaft was microscopically and tactile inspected.Inspection revealed inner shaft damage (buckling and stretched) at 145 mm from the tip of the device, with the shaft intact and not separated.Both ends of the device were pinned with a calibrated pin gage of.014¿.Functional testing was conducted using a test guidewire (.014¿).The test wire was first loaded into the hub of the coyote, and easily advanced approximately 120 cm and stopped at the location of the inner damage, not able to advance past the inner damage.The wire easily loaded into the tip of the device and easily advanced in the inner shaft for approximately 145mm (location of buckling), and then could not be advanced any further, and it took some force to withdraw the wire from the catheter.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-08067.It was reported that catheter entrapment and shaft break occurred.Patient presented with chronic obstructive arterial disease with claudication on movement and was hospitalized.The chronic obstructed target lesion was located in the right below the knee vessel.A 300mm choice¿ guide wire was advanced to the lesion.A 2.5mm x 150mm x 150cm, otw coyote¿ balloon catheter was advanced and dilated the lesion.A small remnant of stenosis was noted and the physician decided to perform additional dilatation.The coyote¿ balloon catheter was re-advanced however; when passing over the guide wire it was noted that it got stuck 140mm from the distal tip of the catheter which does not allow the device to be advanced or withdrawn.When trying to remove the coyote¿ balloon, the shaft broke.The guide wire and the balloon were completely removed from the patient.The wire and the balloon was able to be separated outside the patient's body.The procedure was completed with another of the same device.No patient complications reported, the patient was stable.

• 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: 6816395
• MDR Text Key: 83683834
• Report Number: 2134265-2017-08933
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111295
• 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: 07/26/2017

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: 07/31/2019
• Device Model Number: H74939186251510
• Device Catalogue Number: 39186-25151
• Device Lot Number: 19492060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• 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 Age: 67 YR
• Patient Weight: 72