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

Model Number	24700
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as an approximation as event date was not reported.
Event or Problem Description
It was reported that there was a device packaging issue.A 4.0mmx60mmx135cm (4f) sterling balloon catheter was selected for use.It appeared that the device looked like it was already opened.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2020 as an approximation as event date was not reported.Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The carton, packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The device was returned in a carton and packaging.The device packaging was opened along the vendor seal of the poly-tyvek seal.The bsc seal was intact.The device was in a carrier tube but did not have a balloon protector or product mandrel.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that there was a device packaging issue.A 4.0mmx60mmx135cm (4f) sterling balloon catheter was selected for use.It appeared that the device looked like it was already opened.There were no patient complications reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9943753
• Report Number: 2134265-2020-04777
• Device Sequence Number: 13619638
• Product Code: DQY
• UDI-Device Identifier: 08714729123644
• UDI-Public: 08714729123644
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 04/07/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023607326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1