MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	80617
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event date was not provided, the first date of the month of the aware date was applied.
Event or Problem Description
It was noted that the sterile packaging of the product was contaminated with hair.A 130/20 renegade stc 18 was selected for use for the procedure.Prior to the procedure, upon opening the sterile pack of the reported product, a hair was found inside the package.
Additional Manufacturer Narrative
Event date: the event date was not provided, the first date of the month of the aware date was applied.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade stc-18 micro-catheter in the original packaging and in the unopened sterile pouch.Examination of the packaging showed no damage.The devices pouch was removed from the cardboard box.The sterile pouch was examined for any damage.No damage was noticed on the pouch.It was noticed in the pouch a hair was present.The hair length was approximately 2.5cm long.Inspection of the remainder of the device, except for the foreign material observed revealed no other damage or irregularities.
Event or Problem Description
It was noted that the sterile packaging of the product was contaminated with hair.A 130/20 renegade stc 18 was selected for use for the procedure.Prior to the procedure, upon opening the sterile pack of the reported product, a hair was found inside the package.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8515828
• Report Number: 2134265-2019-03898
• Device Sequence Number: 11452792
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 05/28/2021
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0022314141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1