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	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 peripheral stent system was introduced into a cordis brite tip 4f introducer sheath system and got stuck inside.Upon the attempt to pull the pulsar-18 t3 out of the sheath the stent got released.Thus the introducer sheath and the stent were removed together from the patient.
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 revealed that the distal end of the device has been cut at its distal end and that a maximum of about 10 mm of the inner shaft is missing.The retractable outer shaft is severely deformed over a length of about 30 mm.Outside of the deformed zone the diameter of the retractable outer shaft still complies with the specification.Due to the state of the device a simulation with a reference introducer sheath could not be conducted.The distal end of the device and the stent were not returned for analysis.Review of the production documentation of the product detailed above did not reveal any non-conformity.During final inspection, every stent system undergoes visual inspection for deformations of the outer shaft and the outer diameter is measured over its entire length.The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.It seems likely that the root cause for the complaint event is related to a tolerance issue with the introducer sheath used during the intervention.

• 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: 10364507
• Report Number: 1028232-2020-03219
• Device Sequence Number: 19435238
• 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
• Report Date (Section B): 08/03/2020

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: 12/31/2020
• Device Model Number: 430504
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12193338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1