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

Model Number H74939186251010

Device Problems Leak/Splash (1354); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that the balloon leaked.The target lesion was located in a vessel below the knee.A 2.5mm x 100mm x 150cm coyote¿ balloon catheter was advanced to the lesion.The balloon was inflated to 4 atmospheres on the first inflation however the balloon became scratched and contrast media leaked from the balloon.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

(b)(4).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).

• 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: 4672001
• MDR Text Key: 5734101
• Report Number: 2134265-2015-01815
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

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: 12/31/2017
• Device Model Number: H74939186251010
• Device Catalogue Number: 39186-25101
• Device Lot Number: 17511798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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: 55 YR