MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 6/40/90

Model Number	430459
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The pulsar-18 t3 stent system was selected for the treatment.There was a problem with the guide wire and it had to be replaced.The pulsar-18 t3 device had already been placed inside the artery and had to be removed as well.During removal, the stent got stuck in the cordis 4f introducer and broke.A new 4f cordis introducer and a new pulsar-18 t3 (same lot) were used.When inserted, the device also got stuck in the cordis 4f introducer and broke as well (reported separately).
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 returned instrument has not fractured.In the as-returned state the instrument was stuck inside the 4f cordis brite tip introducer sheath.The outer shaft has been retracted by about 4 cm and the stent has been partially released inside the introducer sheath.Few stent struts and about 1 mm of the device tip protrude from the distal end of the introducer sheath.The distal end of introducer sheath is severely deformed.Also, the retractable outer shaft is severely deformed (i.E.Compressed and kinked) over a length of about 6 cm just proximal to the proximal end of the introducer sheath.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.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 6/40/90
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10488833
• Report Number: 1028232-2020-03772
• Device Sequence Number: 2795483
• Product Code: NIP
• UDI-Device Identifier: 07640130446571
• UDI-Public: 07640130446571
• 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): 09/03/2020

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: 06/16/2023
• Device Model Number: 430459
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07200821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1