MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/150/130; PERIPHERAL DILATATION CATHETER

Model Number 366130

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

A passeo-18 balloon catheter was chosen for treatment a moderately calcified lesion.After passing the v-18 guidewire through the lesion to the distal end of the anterior tibial artery, a serious stenosis of about 30mm was detected.The passeo-18 was introduced and inflated up to 10bar.However, the images showed a leakage of contrast medium and upon withdrawal of the balloon, a pinhole was detected.

Manufacturer Narrative

The returned product was subjected to a 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 technical investigation of the complaint instrument confirmed that the balloon has been inflated and was returned in a partial deflated state.After introduction of a 0.018 inch reference guidewire, functional testing was performed by successfully inflating the balloon with up to 15 atm (rbp).Microscopic inspection of the balloon surface revealed no damage or irregularity.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 pressure test and a helium leakage test.Based on the conducted investigations of the device being subject to this complaint, we can confirm that no product failure could be determined.

• Brand Name: PASSEO-18 2.5/150/130
• Type of Device: 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: 13003101
• MDR Text Key: 282223359
• Report Number: 1028232-2021-06745
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414723
• UDI-Public: 07640130414723
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 366130
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07200780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1