MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2.5/140/150; PERIPHERAL DILATATION CATHETER

Model Number	380339
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 balloon catheter was chosen for pta of a lower leg blood vessel.It was reported that the guidewire (no further information available) came out of the side port instead out of the guidewire lumen of the complaint instrument.Thus, a connection between the guidewire lumen and the inflation lumen was suspected.This was noted after using the balloon several times when the distal portion of the guidewire was still inside the patients body while the defective part of the instrument was outside of the patients body.During the preparations for the intervention, the complaint instrument could be normally flushed.The passeo-14 was used as usual in a standard way and no high pressure device was used.
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 balloon has been inflated.The balloon was partially deflated in the as-returned state with a large amount of blood residue in the balloon- and inflation lumen.After properly flushing and cleaning of the instrument, a severe damage of the inner shaft inside the balloon became apparent.Microscopic inspection revealed that the inner shaft is sliced open over a length of about 9 mm, starting about 23 mm distal to the proximal x-ray marker.The inner shaft is both elongated and compressed distal and proximal to the sliced area.The distance between the two radiopaque markers does not comply anymore with the specification.A 0.014 inch reference guidewire could be normally introduced until reaching the sliced area.The guidewire used in the intervention was not returned for analysis.Review of the production 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 leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PASSEO-14 2.5/140/150
• 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: 17128274
• Report Number: 1028232-2023-02986
• Device Sequence Number: 17754363
• Product Code: LIT
• UDI-Device Identifier: 07640130433755
• UDI-Public: (01)07640130433755(17)2510
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/14/2023

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: 10/02/2025
• Device Model Number: 380339
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09221942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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