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

Model Number UNK719

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Spasm(s) (1966)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.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# 2134265-2017-06620, 2134265-2017-06869, 2134265-2017-06621, 2134265-2017-06769, 2134265-2017-06814.It was reported that the patient experienced a spasm.In (b)(6) 2017 the patient was being treated for atherosclerosis of native arteries of the left leg with ulceration of other parts of the patient¿s foot.The physician visualized the right common femoral artery with ultrasound and found that it was patent.The right common femoral artery was the punctured and a 7 french non bsc sheath was then inserted.The left common femoral artery was catheterized and angiogram of the left common femoral artery was performed.The left common femoral artery was patent, with calcification, plaque and intimal hyperplasia.The left sfa was occluded.The left popliteal artery was occluded.The left anterior tibial artery was occluded.The left tibioperoneal trunk was 50% stenosed.The left posterior tibial artery was 99% stenosed.The left peroneal artery was 50% stenosed.The left dorsalis pedis artery was occluded.The left posterior tibial artery catheterized and angiogram of the left posterior tibial artery was performed.The left posterior tibial artery was 99% stenosed.The left deep plantar arch 1 artery was occluded.The physician catheterized the left lateral plantar artery and performed an angiogram of the left lateral plantar artery.The left lateral plantar artery was patent.Balloon dilation was performed on the 99% stenosed left posterior tibial artery with a 3x220mm coyote balloon catheter, resulting in 0% stenosis post dilation.Balloon dilation was performed on the 50% stenosed left tibioperoneal trunk with a 3x220mm coyote balloon catheter resulting in 0% stenosis post dilation.Atherectomy was performed on the 100% stenosed left sfa using a jetstream xc 2.4/3.4 mm atherectomy device, resulting in 80% stenosis post atherectomy.Atherectomy of the 100% stenosed left popliteal artery was performed with a jetstream xc 2.4/3.4 mm atherectomy device, resulting in 80% stenosis post atherectomy.Balloon dilation was performed on the 80% stenosed left sfa with a 6x200mm sterling balloon catheter, resulting in 0% stenosis post dilation stenosis was 0%.The 80% stenosed left popliteal artery was treated with a 6x200 mm sterling balloon catheter, resulting in 50% stenosis and a dissection.The physician balloon dilated the left common plantar artery with a 2.5x220 mm coyote balloon catheter, resulting in 90% stenosis with thrombus and spasm post dilation.The physician balloon dilated the 100% stenosed left lateral plantar artery with a 2.5 mm by 220 mm coyote balloon catheter, resulting in 90% stenosis with thrombus and spasm.The physician performed thrombectomy on the left lateral plantar artery with a non bsc thrombectomy device and post thrombectomy thrombus and spasm was noted.The patient then received 500 meg of nitroglycerine continuously into the left lateral plantar artery over a prolonged duration.Balloon dilation was then performed on the 30% stenosed left lateral plantar artery with a 2.5x220mm coyote balloon catheter, resulting in 0% stenosis post dilation.The physician catheterized the left peroneal artery and angiogram of the left peroneal artery was performed.The left peroneal artery was occluded, with thrombus.The physician performed a thrombectomy on the left peroneal artery with a non bsc thrombectomy device.Pre-treatment stenosis was 100% with thrombus.Post-treatment stenosis was 70%.The physician balloon dilated the left peroneal artery with a 3 x220mm coyote balloon catheter.Pre-treatment stenosis was 70%.Post-treatment stenosis was 0%.The physician catheterized the left anterior tibial artery and performed angiogram of the left anterior tibial artery.The left anterior tibial artery was occluded.The physician catheterized the left dorsalis pedis artery and performed an angiogram of the left dorsalis pedis artery.The left dorsalis pedis artery was occluded.The left arcuate artery was occluded.The left deep plantar artery was occluded.The left first dorsal metatarsal artery was occluded.The physician catheterized the left deep plantar artery and performed an angiogram of the left deep plantar artery.The left deep plantar artery was 80% stenosed.Balloon dilation the left anterior tibial artery was performed with a 3x220 mm coyote catheter pre-treatment stenosis was 100%.Post-treatment stenosis was 0%.Balloon dilation was performed on the left dorsalis pedis artery with a 2.5x220 mm coyote balloon catheter.Pre-treatment stenosis was 100%.Post-treatment stenosis was 80%.The patient was treated 500 meg of nitroglycerine continuously into the left dorsalis pedis artery over a prolonged duration.Pre-treatment stenosis was 80% with spasm.Post-treatment stenosis was 50%.Balloon dilation was performed on the left dorsalis pedis artery with a 2.5x220mm coyote balloon catheter.Pre-treatment stenosis was 50%.Post-treatment stenosis was 0%.The physician catheterized the left lateral plantar artery.The patient received 500 meg of nitroglycerine and 2.5 mg of verapamil into the left lateral plantar artery.Pre-treatment stenosis was 100% with spasm.Post-treatment stenosis was 50%.The physician catheterized the left deep plantar arch artery and performed an angiogram of the left deep plantar arch artery.The left deep plantar arch artery was occluded.Balloon dilation was performed on the left lateral plantar artery with a 2.5x200mm non bsc balloon catheter.Pre-treatment stenosis was 50%.Post-treatment stenosis was 0%.The physician balloon dilated the left deep plantar arch artery with a 2.5x200mm non bsc balloon.Pre-treatment stenosis was 100%.Post-treatment stenosis was 0%.The physician balloon dilated the left deep plantar artery through the pedal arch with a 2.5x200mm non bsc balloon.Pre-treatment stenosis was 80%.Post-treatment stenosis was 0%.The physician then placed a 6 x60x 75mm innova¿ stent in the left popliteal artery.Post dilation was performed with a 6 mm by 60 mm non bsc balloon.Pre-treatment stenosis was 50% with dissection.Post-treatment stenosis was 0%.The physician performed intravascular ultrasound in the left posterior tibial artery.Findings revealed 0% stenosis, with calcification.The maximum outer wall diameter was 3 mm.Intravascular ultrasound was performed in the left tibioperoneal trunk.Findings revealed 0% stenosis, with calcification.The maximum outer wall diameter was 3 mm.Intravascular ultrasound was performed in the left popliteal artery.Findings revealed 0% stenosis, with calcification.The maximum outer wall diameter was 5 mm.The procedure concluded and the puncture site on the right common femoral artery was closed.No further patient complications were reported and the patient's status was stable.

• Brand Name: COYOTE PTA BALLOON DILATATION CATHETER
• 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: 6667138
• MDR Text Key: 78395858
• Report Number: 2134265-2017-06771
• 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: Physician
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• 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): Required Intervention
• Patient Age: 78 YR