MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 6/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390727
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 stent system was chosen for the treatment but it was not possible to release the stent within the lesion.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed 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could be the cause for the reported event.The technical investigation showed that the distal outer shaft has not been retracted.The stent has not been released.The distal outer shaft has separated from the proximal outer shaft at the gluing between these two shafts.Both, the shaft and the gluing dimensions comply with the specification.However, the shafts show no signs of an increased tensile force application, and during the investigation the stent could be manually released with no unusual friction.The root cause for the complaint event is most likely related to the manufacturing process.To prevent recurrence, the respective internal departments were informed about this case.

• Brand Name: PULSAR-18 US 6/100/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14986748
• Report Number: 1028232-2022-03498
• Device Sequence Number: 1596912
• Product Code: NIP
• UDI-Device Identifier: 07640130436640
• UDI-Public: (01)07640130436640(17)2405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• 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
• Report Date (Section B): 06/22/2022

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: 05/31/2024
• Device Model Number: 390727
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05212926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown