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

Model Number H74939186200610

Device Problems Entrapment of Device (1212); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

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 medwatch will be filed.(b)(4).

Event Description

It was reported that the catheter was perforated by the guide wire and entrapment occurred.A 2.0mm x 60mm x 150cm coyote¿ balloon catheter was advanced inside the patient.During the procedure the guide wire appeared to come out before the tip of the balloon catheter.The physician then encountered difficulty in removing the guide wire and was forced to remove the balloon catheter and the guide wire together.Access was lost as a result.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).Returned product consisted of a coyote balloon catheter with no other devices.There was blood and contrast in the inflation lumen and balloon.The balloon was tightly folded.Functional testing was performed by connecting an inflation device filled with water to the hub.Device was inflated to rated pressure for 5 minutes.Microscopic examination presented no irregularities or defects on the balloon and markerband.Microscopic examination presented no irregularities or defects on the inner/outer shaft.A kinetix plus 0.014¿ guidewire was used for functional testing as the guidewire used in the clinical procedure was not returned for analysis.The inner diameter (id) of the catheter was measured and was within specification.The guidewire was loaded into the device and advanced without any issues.Inspection of the remainder of the device presented no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that the catheter was perforated by the guide wire and entrapment occurred.A 2.0mm x 60mm x 150cm coyote balloon catheter was advanced inside the patient.During the procedure the guide wire appeared to come out before the tip of the balloon catheter.The physician then encountered difficulty in removing the guide wire and was forced to remove the balloon catheter and the guide wire together.Access was lost as a result.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 5083611
• MDR Text Key: 26005841
• Report Number: 2134265-2015-06241
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939186200610
• Device Catalogue Number: 39186-20061
• Device Lot Number: 18063828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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