MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/120/150; PERIPHERAL DILATATION CATHETER

Model Number	366126
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of a moderately calcified lesion (70 percent stenosis degree) in the mildly tortuous ostial renal artery.After dilatation of the passeo-18 balloon catheter, the balloon was blocked and got stuck together with the guidewire.Thus, both devices had to be withdrawn at the same time, but the access got lost and therefore, the operation time was extended for 60 minutes.
Additional Manufacturer Narrative
The returned instrument 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 with the guidewire used in the intervention separately.A fragment of the distal polymer radiopaque coating of the guidewire was stuck in the guidewire lumen and could be removed.The guidewire was stuck due to an unknown reason.The separation of the distal polymer radiopaque coating was most likely caused during removal of the guidewire from the complaint instrument.The provided images did not contain further information regarding the root cause of the complaint event.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.During final inspection a 100 percent control of the guidewire lumen viability is performed.The complaint instrument successfully passed this test.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PASSEO-18 2/120/150
• 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: 15887651
• Report Number: 1028232-2022-06073
• Device Sequence Number: 17455689
• Product Code: LIT
• UDI-Device Identifier: 07640130414686
• UDI-Public: (01)07640130414686(17)2501
• 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): 11/23/2022

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: 01/31/2025
• Device Model Number: 366126
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01222671
• 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: 11/23/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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