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

Model Number H74939134404010

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported that during unpacking device contamination occurred.A 4mm x 40mm x 145cm coyote¿ es balloon catheter was removed from the package when the device flip to the side and was unsterile.The device was not used.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.; visual inspection showed the hub of the device was protruding out the side of the opened product pouch 4mm.The carrier tube (hoop) was positioned in the product pouch with the hub of the device under the tyvek section against the edge of the vendor seal.Inspection of the remainder of the device and packaging revealed no damage or irregularities.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

It was reported that during unpacking device contamination occurred.A 4mm x 40mm x 145cm coyote es balloon catheter was removed from the package when the device flip to the side and was unsterile.The device was not used.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: COYOTE? ES
• 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: 3982790
• MDR Text Key: 4631029
• Report Number: 2134265-2014-04614
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2016
• Device Model Number: H74939134404010
• Device Catalogue Number: 39134-40401
• Device Lot Number: 16920616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1