MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 US 6/150/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	390729
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 peripheral stent system was selected for treatment of a moderately calcified lesion (75 percent stenosis degree) in the mildly tortuous mid sfa.The pulsar 18 stent was delivered to affected lesion area.After snapping red safety, clicked the trigger mechanism and the stent would not deploy.Another pulsar-18 was used effectively.
Additional Manufacturer Narrative
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 stent is still fully crimped under the distal outer shaft.The distal outer shaft has separated from the proximal outer shaft at the gluing between the two shafts.Consequently, only the proximal outer shaft is retracted when pressing the trigger at the handle.Both the shaft and the gluing dimensions comply with the specification.Review of the production documentation confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no material or manufacturing related root cause could be identified.The final root cause for the reported event could not be determined.

• Brand Name: PULSAR-18 US 6/150/135
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12127101
• Report Number: 1028232-2021-03779
• Device Sequence Number: 3428122
• Product Code: NIP
• UDI-Device Identifier: 07640130436664
• UDI-Public: 07640130436664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 09/30/2023
• Device Model Number: 390729
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10204672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization