MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 6/20-180/128; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	454338
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An oscar peripheral multifunctional catheter system was selected for treatment of a severely calcified lesion (80 percent stenosis degree) in the moderately tortuous distal rca.The oscar was used cross over from the left to the right distal sfa and inserted with the dilatator in position 0.Only the dilator could be pushed from the middle sfa further down but not the support catheter, so it was decided to exchange the dilatator with the 6mm pta balloon.During pulling the dilatator out, massive friction was noticed.Everything was straight, no kink of the wire was noticed.During pulling the dilatator out, the shaft broke where the metal shaft ends and overlaps to the plastic shaft.It was possible to take the dilatator fully out.Another balloon was used.The intervention was successfully completed.
Additional Manufacturer Narrative
The returned product 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 this event.In addition, the provided image of an angiogram was reviewed.The technical investigation of the oscar dilator revealed that parts of the calcification were found embedded into the polymer body of the oscar dilator tip, surrounded by deep scratches.As a consequence of the reported blockage, the shaft of the oscar dilator has separated from the hub due to the application of a high tensile force.The oscar support catheter was not returned for investigation.On the provided image, one single screenshot of the angiogram of the patients aorto-iliac bifurcation is shown.A steep angle as described in the complaint description could be confirmed.However, the complaint event is not visible in the image.Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During the final packaging, the oscar dilator and the oscar support catheter were assembled together before inserting the system into the transportation loop.Any unusual friction would have been detected.The tensile strength of the oscar dilator shaft gluing to the hub is tested by means of manufacturing process output monitoring.Based on the conducted investigations, no material or manufacturing related root cause was identified.Considering the physicians description of the lesion, the root cause for the reported friction is most likely related to the patients anatomy, i.E., the high kink in the bifurcation blocking the oscar dilator against the oscar support catheter.The separation of the oscar dilator shaft from the hub is most likely related to the handling, i.E., the application of a high tensile force despite feeling resistance.

• Brand Name: OSCAR 6/20-180/128
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17483370
• Report Number: 1028232-2023-03970
• Device Sequence Number: 20541755
• Product Code: LIT
• UDI-Device Identifier: 07640130455757
• UDI-Public: (01)07640130455757(17)2602
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K214038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: 02/18/2026
• Device Model Number: 454338
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02230307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown