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

Model Number H74939185202210

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified and moderately tortuous below the knee.A 2.0mmx220mmx150cm coyote balloon catheter was advanced for dilatation.However, during the first inflation the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote balloon catheter.The balloon was loosely folded, with blood and contrast in the balloon and lumen.Functional testing was performed by connecting an inflation device filled with water to the hub.When pressure was applied, water was found to be leaking from the balloon.Microscopic examination found a pinhole 18 cm from the tip of the device.Microscopic inspection of the markerband found no irregularities or defects.Microscopic inspection on the tip found no irregularities or defects.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified and moderately tortuous below the knee.A 2.0mmx220mmx150cm coyote¿ balloon catheter was advanced for dilatation.However, during the first inflation the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5300635
• MDR Text Key: 33587743
• Report Number: 2134265-2015-08771
• 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,Followup
• Report Date: 11/30/2015

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: 07/31/2018
• Device Model Number: H74939185202210
• Device Catalogue Number: 39185-20221
• Device Lot Number: 18232058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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