MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 3.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367019
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was intended to treat a mildly calcified eccentric type b1 lesion (95 percent stenosis degree,) in a segment of the rca.The lesion was pre-dilated with the pantera pro 2.5/20 compliant balloon catheter once, followed by a pantera leo 3.5/15 nc balloon catheter, which was inflated twice.After this pre-dilatation, a localized dissection was noted in the treated area.Subsequently, a scaffold was implanted and post-dilatation was done.Thereby the dissection was fixed.Both balloon catheters are reported separately.
Additional Manufacturer Narrative
The complaint instrument was not provided for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided angiographic material and the clinical documentation was reviewed.Review of the product release documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.The provided angiographic material was reviewed.It is visible that the lesion was pre-dilated with a 2.5/20 balloon catheter, which caused the initiation for a dissection.Further it is visible that the second predilatation with the complaint instrument caused the localized dissection.A scaffold has been implanted and was post-dilated which fixed the dissection.Based on the conducted investigations no manufacturing related root cause could be identified.

• Brand Name: PANTERA LEO 3.5/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• 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: 17004053
• Report Number: 1028232-2023-02692
• Device Sequence Number: 7168715
• Product Code: LOX
• UDI-Device Identifier: 07640130415775
• UDI-Public: (01)07640130415775(17)2507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• 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
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2025
• Device Model Number: 367019
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06224512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown