MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PANTERA LEO 4.0/12; BASIC CORONARY ANGIOPLASTY BALLOON CATHETER

Model Number	367010
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, a 4.0/12 pantera leo nc balloon was requested and was given a 4.0/12 box from the shelf.The inner bag was opened, and the balloon was handed over to the physician.On use, patient consequence: stent hematoma and dissection (confirmed in ivus) as well as stent overexpansion.Patient was stable at end of procedure.After checking when writing up the report, it was detected that an nc 4.5 balloon had been scanned in the list of materials, whereas he had requested a 4.0.After the team checked the packaging in the garbage can, the balloons inner packaging was a 4.5/12 and not a 4.0 as indicated on the outer cardboard box.
Additional Manufacturer Narrative
The packaging of the complaint product was not returned.The corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the two images provided by the local staff were reviewed.The technical investigation of the provided images of the cardboard box indicates a pantera leo 4.0/12 (lot 06215322, ref.(b)(4)) whereas the inner label indicates a pantera leo 4.5/12 (lot 08224156, ref.(b)(4)).Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.A different number of instruments has been manufactured in the two suspected lots.No record of a mismatch in the number of processed instruments has been documented.No reprinting of new labels and no destroying of redundant labels is recorded at final packaging for both lots.The printing of the inner label as well as the outer label is performed simultaneously in one process and cannot be mixed between two lots.Table clearing is performed in the labelling process as well as in the packaging process.The two lots have been processed with a minimum time difference of 406 days.Therefore, there could be no internal mix-up between these two lots.None of the two lots has been reworked.Both lots have been sent to the relevant hospital with at least 10 instruments.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: PANTERA LEO 4.0/12
• Common Device Name: BASIC CORONARY ANGIOPLASTY BALLOON 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: 17777660
• Report Number: 1028232-2023-04667
• Device Sequence Number: 6669057
• Product Code: LOX
• UDI-Device Identifier: 07640130415683
• UDI-Public: (01)07640130415683(17)2407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163660
• 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,Followup
• Report Date (Section B): 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 367010
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06215322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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