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

Model Number 430504

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10364507
• MDR Text Key: 201604386
• Report Number: 1028232-2020-03219
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 07640130447028
• UDI-Public: 07640130447028
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1