MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY MUSTANG¿; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H74939171080670
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a foreign material was found in the sterile packaging.A 8.0 x 60 mustang¿ balloon catheter was selected for use.However, during preparation, it was noted that a hair was found in the sterile packaging of the device.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was returned for analysis.The pouch had been opened prior to receipt at the investigation site containing the unused device that was still in the carrier tube.The foreign matter (fm) was present on the packaging (pouch).The fm was microscopically examined and was confirmed to be a hair follicle due to the presence of root at the base of the follicle.The follicle measured 5mm in length.As the pouch had already been opened prior to receipt at the investigation site, it cannot be determined where the hair follicle originated from.No other 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 was unable to be determined.(b)(4).
Event or Problem Description
It was reported that a foreign material was found in the sterile packaging.A 8.0 x 60 mustang¿ balloon catheter was selected for use.However, during preparation, it was noted that a hair was found in the sterile packaging of the device.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: MUSTANG¿
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6225432
• Report Number: 2134265-2016-12280
• Device Sequence Number: 10773889
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: (01)08714729793885(17)20191024(10)19882883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: H74939171080670
• Device Catalogue Number: 39171-08067
• Device Lot Number: 19882883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1