MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 3/80/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	383235
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 was selected for treatment of a mildly calcified lesion (stenosis degree: 80 percent) in the moderately tortuous mid arteriovenous fistula.The patient was prepared, and guidewire was inserted, followed by the insertion of the passeo-35 balloon for pre-dilatation.However, the balloon failed to inflate properly.It could not be inflated to the nominal pressure.The balloon was withdrawn and replaced with the same model and inflated normally.
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 the passeo-35 balloon is leaking from a gluing hole in the hub.Microscopic investigation revealed an incompletely filled gluing hole on one side of the hub causing the leakage.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.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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 the passeo-35 balloon is leaking from a gluing hole in the hub.Microscopic investigation revealed an incompletely filled gluing hole on one side of the hub causing the leakage.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 3/80/90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 19207948
• Report Number: 1028232-2024-02388
• Device Sequence Number: 12744494
• Product Code: LIT
• UDI-Device Identifier: 07640130434172
• UDI-Public: (01)07640130434172(17)2609
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K082933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 09/09/2026
• Device Model Number: 383235
• Device Catalogue Number: 383235
• Device Lot Number: 08230542
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 10/29/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/08/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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