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

Model Number H74939186202210

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the catheter froze on the wire.The target lesion was located in the posterior tibial artery.After a.014 non-bsc guide wire crossed the lesion, a 2.5x120 coyote balloon catheter was advanced for dilation.Upon removal, it took some effort to get the balloon off the wire.The device eventually released from the wire, wire position was maintained and the procedure was completed with a non bsc balloon catheter.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the balloon catheter was completely stuck with the guide wire and everything had to be removed.While outside the patient, there was still difficulty in removing the wire.

Manufacturer Narrative

Upn- search corrected from unk719 - coyote - cmc - maple grove (peripheral interv) - 35000 to h74939186202210 - coyote, 2.0mm x 220mm x 150cm, otw - 39186-20221.Upn corrected from unk719 to h74939186202210.Catalog/model # updated.(b)(4).

Event Description

It was further reported that the balloon catheter was completely stuck with the guide wire and everything had to be removed.While outside the patient, there was still difficulty in removing the wire.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7048757
• MDR Text Key: 93175751
• Report Number: 2134265-2017-11459
• 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,Followup,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939186202210
• Device Catalogue Number: 39186-20221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• 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