MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24690
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that foreign material was found in the device.A 3.5mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, during unpacking, a hair was found on the holder of the device.No patient complications were reported.
Event or Problem Description
It was reported that foreign material was found in the device.A 3.5mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, during unpacking, a hair was found on the holder of the device.No patient complications were reported.
Additional Manufacturer Narrative
Initial reported city (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter inside the packaging.The product package, pouch, and device were visually inspected.The box and pouch were both open.The pouch was opened along the poly-tyvek seal.The bsc seal was still intact.The device was still in its carrier tubing.There was foreign matter consisting of a hair on the carrier tube inside the pouch.Inspection of the remainder of the packaging and device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8734414
• Report Number: 2134265-2019-06631
• Device Sequence Number: 11406265
• Product Code: DQY
• UDI-Device Identifier: 08714729756910
• UDI-Public: 08714729756910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 01/25/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0021666690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1