MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4.0/20-180/128

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Event occurred while using oscar attempting a cto lesion in the sfa.Stopcock on side support was left open and bleed back was noticed.When aspirating and flushing, air was noticed in the system.Tuohy was checked and was tight and locking collar was in lock position.System was then removed from patient.System was flushed and while flushing, fluid was noticed coming out behind the white tip control barrel.Apparently, there is a crack or faulty piece in the system.

Manufacturer Narrative

Only the oscar pta balloon was returned and subjected to a detailed technical analysis.The production documentation of the affected oscar support catheter and oscar dilator was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The oscar pta balloon was returned inside the ring protector with the protective tubing applied covering the entire balloon.The instrument shows no signs of use and is undamaged besides a mild kink at the distal end of the metal tube.The affected oscar support catheter and oscar dilator were not returned.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be identified.

• Brand Name: OSCAR
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 17347625
• MDR Text Key: 319431027
• Report Number: 1028232-2023-03575
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130455771
• UDI-Public: (01)07640130455771(17)260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.0/20-180/128
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02230295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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