MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/80/150; PERIPHERAL DILATATION CATHETER

Model Number	366123
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment of a moderately calcified lesion (60 percent stenosis degree) in the moderately tortuous anterior tibial artery.The balloon was placed in the lesion and inflated up to 6 bar.Then, imaging showed leaking contrast medium.The device was withdrawn and another balloon was used to complete the intervention.
Additional Manufacturer Narrative
The returned product was subjected to a 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 technical investigation of the complaint instrument confirmed that the balloon has been inflated and was returned in a partial deflated state.After introduction of a 0.018 inch reference guidewire, functional testing was performed by successfully inflating the balloon with up to 15 atm (rbp).Microscopic inspection of the balloon surface revealed no damage or irregularity.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leakage test.Based on the conducted investigations of the device being subject to this complaint, we can confirm that no product failure could be determined.

• Brand Name: PASSEO-18 2/80/150
• Common Device Name: PERIPHERAL DILATATION 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: 12834609
• Report Number: 1028232-2021-06318
• Device Sequence Number: 4639191
• Product Code: LIT
• UDI-Device Identifier: 07640130414655
• UDI-Public: 07640130414655
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• 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): 11/17/2021

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: 04/30/2024
• Device Model Number: 366123
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04212886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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