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

Model Number H74939135152010

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that removal difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2.0-2.5mm.A 3.3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed.A non-bsc 2.0-100mm balloon catheter was advanced but unable to cross the lesion.Then a 1.5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds.Then the device was caught by the calcification and it could not be moved at all.Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved.After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated.But it still could not be removed even after pulling the shaft.About 20cm distal part of the shaft was detached and it remained inside the patient's body.The procedure was ended.Distal bypass surgery is scheduled at a later date due to decrease in blood flow.7 days later surgical operation was performed successfully.The distal part of the posterior tibial artery was opened surgically.The detached balloon and distal tip were removed.Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery.The patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned device consisted of a coyote es balloon catheter in two pieces.There was blood and contrast in the balloon, wire lumen and inflation lumen.The tip, balloon, markerbands, proximal weld, inner/outer shaft, port/exit notch were microscopically, tactile and visually inspected.Inspection revealed; a complete separation (stretched) in the shaft (outer and inner shafts) located just distal of the port/exit notch (24 cm from the tip), numerous kinks in the distal shaft, balloon bunching with the distal end of the balloon prolapsing near the tip, tip damage (stretched/shredded), and port weld damage (stretched/focally necked/top of port ripped).Functional testing could not be performed due to the excessive damage to the device.Inspection of the remainder of the device revealed no other damage or irregularities.The reported information indicates the device was inflated over rated burst pressure.The physician intentionally inflated balloon over rated burst pressure in an effort to remove the device from the patient¿s anatomy.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 removal difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2.0-2.5mm.A 3.3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed.A non-bsc 2.0-100mm balloon catheter was advanced but unable to cross the lesion.Then a 1.5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds.Then the device was caught by the calcification and it could not be moved at all.Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved.After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated.But it still could not be removed even after pulling the shaft.About 20cm distal part of the shaft was detached and it remained inside the patient's body.The procedure was ended.Distal bypass surgery is scheduled at a later date due to decrease in blood flow.7 days later surgical operation was performed successfully.The distal part of the posterior tibial artery was opened surgically.The detached balloon and distal tip were removed.Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery.The patient¿s status was stable.

• 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: 7118062
• MDR Text Key: 94866318
• Report Number: 2134265-2017-12377
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: H74939135152010
• Device Catalogue Number: 39135-15201
• Device Lot Number: 20413171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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
• Treatment: ASTATO 9-12 AND PROMINENT GUIDEWIRE; CRUISE 014 GUIDEWIRE; ICHIBANYARI PAD2 GUIDEWIRE; INFLATION DEVICE: ENCORE 26; INTRODUCER SHEATH: PARENT 3.3FR; MASTULY 2.0-100MM
• Patient Outcome(s): Required Intervention