MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA PRO 1.5/15; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	393299
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pantera pro coronary dilatation catheter was chosen for treatment of a moderately calcified lesion (95 percent stenosis degree) in the moderately tortuous proximal rca.When removing the transportation wire, the balloon was stuck to the wire and tore off the delivery system.It was not recognized, and the device was introduced into the guiding catheter.Because the balloon was not seen in the imaging the device was removed.Another balloon was used to complete the intervention.Udi (b)(4).
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The instrument was returned fractured in two parts.The distal fragment (including balloon) is stuck on the transportation wire and partially covered by the balloon protector.The balloon protector has been pulled over the loop at distal end of transportation wire.The fracture site is located at the proximal balloon weld.The inner shaft is severely deformed.Also, the device tip is severely deformed and has necked near the tip weld, both indicating application of a high tensile force.Backscatter electron imaging and energy-dispersive x-ray spectroscopy of both the device tip inner surface and transportation wire outer surface revealed contrast medium residue which may have contributed to the complaint event.Moreover, simulations have shown that a similar damage pattern as observed in the returned instrument could be reproduced by wrong handling (e.G.Grabbing the balloon protector in the tip area when pulling).Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.The transportation wire is moved several times during production.As part of the inner packaging process each instrument is inspected for damages (100 percent control) and the position of the transportation wire is checked and corrected, if necessary.Based on the conducted investigations, no manufacturing or material related root cause could be determined.Please note that the ifu advises the user to pull the plunger of the inflation/deflation device and aspirate air from the catheter prior to introduction, and to not use the catheter if a vacuum cannot be held, as this indicates a system failure.

• Brand Name: PANTERA PRO 1.5/15
• 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: 15188171
• Report Number: 1028232-2022-04008
• Device Sequence Number: 6612480
• Product Code: LOX
• UDI-Device Identifier: 07640130437036
• UDI-Public: (01)07640130437036(17)2210
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160985
• 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): 08/08/2022

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: 10/23/2022
• Device Model Number: 393299
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10193497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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