MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 1.5/70/150; PERIPHERAL DILATATION CATHETER

Model Number	380325
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 balloon catheter was selected for treatment.The passeo-14 balloon could not be inflated as it reached the lesion below the knee.Upon removal a leakage was found in the balloon, and another device was used for the procedure.The balloon was scrapped by the hospital and could not be returned.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the instruments were 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 helium leak test and a pressure test.Only the instruments which pass these tests are further processed.The instruments were delivered in a leak-proof and pressure-tight condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PASSEO-14 1.5/70/150
• 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: 15986441
• Report Number: 1028232-2022-06424
• Device Sequence Number: 5961815
• Product Code: LIT
• UDI-Device Identifier: 07640130433618
• UDI-Public: (01)07640130433618(17)2411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152240
• 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): 12/13/2022

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: 11/30/2024
• Device Model Number: 380325
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11212175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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