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

Model Number H74939135254010

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of the coyote es balloon catheter in two pieces.The balloon, tip, hypotube and shaft were microscopically examined.There was contrast in the inflation lumen and blood between the balloon folds.The balloon was tightly folded.There were numerous kinks throughout the hypotube and there was a complete hypotube separation 75.5 cm from the strain relief.The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation.The tip was damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 01-jun-2017.It was reported that crossing difficulties were encountered.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery (ata).A 2.5 mm x 40 mm x 146 cm coyote¿ es balloon catheter was advanced for dilation but failed to cross the lesion.The procedure was completed using a non-bsc balloon catheter.No patient complications were reported and the patient's status was good.However, returned device analysis revealed a hypotube break.It was further reported that resistance was encountered when advancing the complaint device to the lesion.During removal of the device, no resistance was encountered but the hypotube got separated and a snare was used to remove the device.

• 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: 6631086
• MDR Text Key: 77243702
• Report Number: 2134265-2017-06039
• 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,distri
• 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: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: H74939135254010
• Device Catalogue Number: 39135-25401
• Device Lot Number: 0019576920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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
• Treatment: GUIDE WIRE: COMMAND; INFLATION DEVICE: MEDTRONIC; INTRODUCER SHEATH: MEDIKIT
• Patient Outcome(s): Required Intervention