MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG STYLET S 60-F; ACCESSORY

Model Number	124697
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The inner packaging of this stylet was not sealed.
Additional Manufacturer Narrative
We received your event description and the pictures for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information and the pictures you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.In the course of the analysis of the provided pictures, no deviations were noted.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing and packaging process.The analysis did not reveal any sign of a material or manufacturing problem.Biotronik monitors the post-market performance of its products sensitively in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.
Additional Manufacturer Narrative
(b)(6) 2019 - revised evaluation codes.We received your event description and the pictures for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information and the pictures provided have been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.In the course of the analysis of the provided pictures, no deviations were noted.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing and packaging process.The analysis did not reveal any sign of a material or manufacturing problem.Biotronik monitors the post-market performance of its products sensitively in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.

• Brand Name: STYLET S 60-F
• Common Device Name: ACCESSORY
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8285924
• Report Number: 1028232-2019-00271
• Device Sequence Number: 1556874
• Product Code: DTB
• UDI-Device Identifier: 04035479145057
• UDI-Public: 04035479145057
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

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 Model Number: 124697
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06186124
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 02/11/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/26/2019; 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1