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

Model Number H74939186202210

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote balloon catheter received inside the opened product pouch.The batch number on the returned packaging and device matched the reported batch number.The seal of the product pouch was opened on the left side where the tyvek and poly material meet.The area of separation from tyvek and poly shows a residual of tyvek material which indicates a seal was present between the tyvek and the poly material.Uniform witness marks on the side seal give no visual or tactile indication of a possible seal defect.The product pouch was open, as-received in the cis lab; however, there was no evidence of a defective seal and no indication that the pouch was opened prior to shipment from bsc.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that sterility was compromised.During unpacking of a 2.0mmx220mmx150cm coyote¿ balloon catheter, it was noticed that the inner packaging of the device was damaged.No patient complications were reported as the device did not enter the patient's body.

• 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: 7171962
• MDR Text Key: 96627852
• Report Number: 2134265-2017-13204
• 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
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: H74939186202210
• Device Catalogue Number: 39186-20221
• Device Lot Number: 21366062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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
• Patient Age: 74 YR