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

Model Number H74939186302290

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: 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 med watch will be filed.(b)(4).

Event Description

It was reported that catheter entrapment and the balloon was stripped.A 3.0mm x 220mm x 90cm coyote¿ balloon catheter was selected for use to treat a lesion.However during preparation, it was noted that the guidewire became stuck in the balloon catheter and the balloon was stripped.The device was never used inside the patient's body.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id# 2134265-2017-09400.It was further reported that the guide wire that became stuck inside the 3.0mm x 220mm x 90cm coyote¿ balloon catheter was a v-14 control 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: 6840548
• MDR Text Key: 85004633
• Report Number: 2134265-2017-08431
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K111295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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: 05/22/2020
• Device Model Number: H74939186302290
• Device Catalogue Number: 39186-30229
• Device Lot Number: 20679154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 09/02/2017
• Supplement Dates Manufacturer Received: 09/03/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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