MAUDE Adverse Event Report: BIOTRONIK AG PANTERA LEO 3.75/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367020
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
9/30/2019 - at the request of the fda, submitting an initial report since the first report was submitted as a supplemental by mistake.It was intended to tread a severely calcified lesion (stenosis degree 90 percent, vessel diameter 3.75mm) in the proximal rca.The returned instrument was subjected to a 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.In addition angiographic material was reviewed.The returned balloon is well folded and shows no signs of inflation.The folded balloon profile was measured to be within specifications.The angiographic material confirmed the reported event.Review of the production 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The reported difficulty in lesion crossing is most likely related to the severely calcified high degree stenosis.
Event or Problem Description
Ous mdr - the device could not pass the severely calcified lesion.9/30/2019 - at the request of the fda, submitting an initial report since the first report was submitted as a supplemental by mistake.
Additional Manufacturer Narrative
It was intended to tread a severely calcified lesion (stenosis degree 90 percent, vessel diameter 3.75mm)in the proximal rca.The returned instrument was subjected to a 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.In addition angiographic material was reviewed.The returned balloon is well folded and shows no signs of inflation.The folded balloon profile was measured to be within specifications.The angiographic material confirmed the reported event.Review of the production 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.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The reported difficulty in lesion crossing is most likely related to the severely calcified high degree stenosis.
Event or Problem Description
Ous mdr - the device could not pass the severely calcified lesion.

• Brand Name: PANTERA LEO 3.75/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 7511231
• Report Number: 1028232-2018-01663
• Device Sequence Number: 16851582
• Product Code: LOX
• UDI-Device Identifier: 07640130415782
• UDI-Public: 07640130415782
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K163660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 05/31/2020
• Device Model Number: 367020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05175091
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1