MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 5/100/130; CATHETER

Model Number	428889
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 xeo balloon catheter was selected for pre-dilatation of a moderately calcified lesion in the mildly tortuous proximal to mid sfa.It was not possible to inflate the balloon, even the pressure was held at 9 atm.The inflation device was checked and no problem was found.A second attempt of inflation was made but the balloon still did not inflate.
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 the reported event.The technical investigation confirmed that inflation of the balloon was impossible as the entrance of the inflation lumen in the hub was covered by a transparent polymer tube.The root cause for the reported event is therefore most likely related to the manufacturing process.The relevant internal departments were informed about the investigation results.

• Brand Name: PASSEO-35 XEO 5/100/130
• Common Device Name: 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: 18242797
• Report Number: 1028232-2023-06061
• Device Sequence Number: 15218627
• Product Code: LIT
• UDI-Device Identifier: 07640130452602
• UDI-Public: (01)07640130452602(17)2603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222065
• 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): 04/29/2024

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: 03/19/2026
• Device Model Number: 428889
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02235665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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