MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PULSAR-18 T3 6/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430504
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment.The stent could not be released.
Additional Manufacturer Narrative
On 8-apr-2020 - lot number was incorrect on first submission.Correct number is 10196169.
Additional Manufacturer Narrative
(b)(6) 2020 - lot number was incorrect on first submission.Correct number is 10196169.The returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the retractable shaft has separated from the bushing which is connected to the pull-wire being intended to release the stent.This most likely occurred during intervention when it was attempted to release the stent.Microscopic inspection revealed a rather small amount of remaining glue on the outside of the retractable shaft and on the inside of the bushing.This finding indicates that that the root cause for the complaint event is most likely related to the manufacturing process of a subassembly manufactured by a supplier.The retractable shaft has been retracted by about 8.5 mm.The distal end of the stent is visible.The stent has not been released.To prevent recurrence the respective internal departments were informed about this case and we are reviewing our quality systems processes.The supplier of the affected subassembly was informed about the complaint.

• Brand Name: PULSAR-18 T3 6/150/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9935720
• Report Number: 1028232-2020-01612
• Device Sequence Number: 14077886
• Product Code: NIP
• UDI-Device Identifier: 07640130447028
• UDI-Public: 07640130447028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 10/31/2020
• Device Model Number: 430504
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10196169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 05/27/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/09/2020; 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1