MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/120/130; PERIPHERAL DILATATION CATHETER

Model Number	357508
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 peripheral balloon catheter was selected for treatment of a moderately calcified lesion (stenosis degree: 50 percent) in the moderately tortuous posterior tibial artery (pta).The passeo-18 was inflated at the pta lesion at 6 atm.However, as the balloon was inflating, it was observed that blood was flowing into the inflation device.It was suspected that the balloon was ruptured but the balloon was able to inflate and maintained at 6 atm even though blood continue to flow into the inflation device.The balloon was deflated and removed from the patient without difficulties.A new balloon was used and the lesion successfully dilated.
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 affected balloon has been inflated and was returned fully deflated.During functional testing a fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection showed a pinhole about 25 mm proximal to the distal radiopaque marker.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.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 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).
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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 affected balloon has been inflated and was returned fully deflated.During functional testing a fine jet of water was seen to emerge from the distal balloon portion.Microscopic inspection showed a pinhole about 25 mm proximal to the distal radiopaque marker.In close vicinity to the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.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 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 3/120/130
• 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: 19219900
• Report Number: 1028232-2024-02402
• Device Sequence Number: 6904484
• Product Code: LIT
• UDI-Device Identifier: 07640119559193
• UDI-Public: (01)07640119559193(17)2502
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2024

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: 02/28/2025
• Device Model Number: 357508
• Device Catalogue Number: 357508
• Device Lot Number: 01222665
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/29/2024; 11/01/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/30/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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