MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND OSCAR 3/20-180/127; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 454334

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

An oscar peripheral multifunctional catheter system was selected for treatment of a moderately calcified cto in the mid-section of the anterior tibial artery.A 200cm v-14 guide wire was used in combination with the oscar.First inflation with 8bar could be successfully performed.During the attempt to advance the guide wire further distal, the wire looped, and the oscar pta was pushed forward.Guide wire got damaged and showed a wrinkling at the distal end.It was not possible to remove the guidewire through the oscar pta.Therefore, wire was removed together with oscar pta.The hydrophilic coating of the wire at the distal end was peeled off and created the wrinkling.A new wire was introduced into the already used oscar pta and introduced into the patient.During the second attempt of inflation, it was noticed that the oscar pta balloon leaked.

Manufacturer Narrative

07-feb-2024 updated description an oscar peripheral multifunctional catheter system was selected for treatment of a moderately calcified cto in the mid-section of the anterior tibial artery.The occlusion could be crossed with a 0.014 inch guide wire, followed by the oscar dilator.The oscar support catheter could only follow up to the middle of the occlusion.The oscar dilator was exchanged with the 3.0 mm oscar pta balloon (complaint device), due to the short guide wire, the guide wire had to be withdrawn and backloaded outside of the patient.The oscar pta balloon was introduced and successfully inflated with 8 atm.After inflation of the balloon, the guide wire was pushed further but got looped and the balloon was pushed forward.The guidewire got damaged and showed a wrinkling at the distal end, following it was not possible to remove the guidewire.Both, guide wire and oscar pta balloon were removed, and a damage to the hydrophilic coating of the guide wire was confirmed.A new wire was introduced, and the balloon was positioned in the target lesion.A second inflation was not possible as the oscar pta balloon leaked.The physician assumed that the guidewire has damaged the oscar pta balloon.A second oscar pta balloon was introduced together with the new guide wire.During manipulation, the second guide wire got damages as well, the hydrophilic coating got peeled off (reported separately).Both, guide wire and second oscar pta balloon were withdrawn, and the intervention was finalized using a standard pta balloon.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 revealed a damage to the tip and to the balloon, a long tear is visible along the entire tip up to the distal balloon shoulder confirming the narrative of the physician.The balloon has been inflated and was returned in a partially deflated state.Review of the production documentation confirmed that the product was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each product is tested for air tightness by means of a pressure test.We can therefore confirm that the product was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the guide wire used during the intervention (i.E., the guide wire cut the device tip).

• Brand Name: OSCAR 3/20-180/127
• 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: 18489686
• MDR Text Key: 332995494
• Report Number: 1028232-2024-00128
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K214038
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 454334
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02232459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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