MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 4.0/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367021
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera leo coronary balloon catheter was selected for treatment.After the balloon was inflated 4 times at max.16 bar, the sheath of the balloon has been destroyed.The balloon needed to be removed together with the guide.
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.In addition, the angiographic material provided was reviewed.The balloon was partially deflated in the as returned state with a rather large amount of contrast medium residue in the balloon and inflation lumen.Microscopic inspection revealed that the inner lumen is severely deformed in the balloon area, indicating application of a high tensile force.At the distal outer shaft the hydrophilic coating has delaminated over a length of about 75 mm.A severe axial oriented coating abrasion was observed proximal to the delaminated area which implies that a flat or mechanical deformable media has likely caused a dimensional conflict.Mir/atr spectroscopy confirmed that the instrument was coated according to specifications.The guidewire(s) and the guiding catheter used in the intervention were not returned for analysis.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The actual complaint event is not visible in the angiographic material provided.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all 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.

• Brand Name: PANTERA LEO 4.0/15
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10928976
• Report Number: 1028232-2020-05218
• Device Sequence Number: 2469804
• Product Code: LOX
• UDI-Device Identifier: 07640130415799
• UDI-Public: 07640130415799
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2020

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: 08/31/2023
• Device Model Number: 367021
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08203072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1