MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 T3 5/60/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	430450
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pulsar-18 t3 stent system was chosen for treatment of a pre-dilated moderately calcified lesion (90 percent stenosis degree) in a mildly tortuous proximal sfa.After stent deployment it was necessary to take off the stent system together with the guidewire.It was noticed that the shaft was completely wrinkled catching the guidewire.After stretching the shaft it was possible to remove the guidewire.
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 both the braided outer shaft and the stabilizer shaft are kinked and deformed.The stabilizer shaft has wrinkled at the transition to the handle lever.The damage pattern indicates that the braided outer shaft has been pulled too far back into the stabilizer shaft and was thus blocked from movement, inducing a wrinkling of the blue stabilizer shaft at the transition to the handle lever.This may slightly affect mobility of the guidewire in the guidewire lumen.However, the distal shaft deformations have probably contributed to the reduced mobility.A 0.018 inch reference guidewire could be introduced into the guidewire lumen of the returned instrument without unusual friction.The guidewire used in the intervention was not returned for analysis.A simulation was conducted with a reference pulsar-18 t3 and 0.018 inch guidewire.After inducing a damage of the stabilizer shaft as seen in the complaint instrument slightly increased friction was felt when moving the guidewire in the guidewire lumen, but it was not blocked.Review of the production documentation confirmed that 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.

• Brand Name: PULSAR-18 T3 5/60/90
• 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: 10813204
• Report Number: 1028232-2020-04817
• Device Sequence Number: 17166255
• Product Code: NIP
• UDI-Device Identifier: 07640130446489
• UDI-Public: 07640130446489
• 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): 11/05/2020

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: 03/12/2023
• Device Model Number: 430450
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02205670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1