MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/200/130; PERIPHERAL DILATATION CATHETER

Model Number	376297
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment of a moderately calcified lesion (75 percent stenosis degree in the mildly tortuous anterior tibial artery.A 5f short sheath was inserted into the right common femoral artery.0.18 inch wire is used to cannulate pass the lesion in the anterior tibial artery.The wire is parked at the distal anterior tibial artery.The balloon was then inflated to 6 atm.Balloon pressure unable to stay at 6 atm.On the angiogram, contrast can be seen leaking out from the balloon.Balloon is properly deflated and removed out of the patients body.
Additional Manufacturer Narrative
The returned product 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 the reported event.The affected balloon has been inflated and was deflated in the as returned state.Upon inflation up to 6 atm (np) the balloon opened normally but the pressure did not hold.A fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection revealed a pinhole nearby the distal x-ray marker.In close vicinity to the pinhole a long deep scratch was observed which has likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.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 helium leak test and a pressure test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause was determined.The root cause for the reported event is most likely related to the patients anatomy (i.E.Calcified lesion).

• Brand Name: PASSEO-18 2.5/200/130
• 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: 16383831
• Report Number: 1028232-2023-00852
• Device Sequence Number: 5514647
• Product Code: LIT
• UDI-Device Identifier: 07640130430044
• UDI-Public: (01)07640130430044(17)2510
• 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): 02/15/2023

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: 10/03/2025
• Device Model Number: 376297
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09223317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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