MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 8/40/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428791
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pta shunt procedure, the passeo-35 xeo balloon was inflated up to 22 atm and ruptured circular.A part of the balloon remained in the vessel when it was removed.The remaining part of the balloon was removed by surgery.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The instrument was returned fractured in two parts.The distal fragment was not returned.The proximal fragment has a length of about 866 mm.The balloon has burst in transversal direction about 31 mm distal to the proximal balloon weld.Microscopic inspection revealed scratches on the balloon surface in close vicinity to the tearing edge.The inner shaft has fractured just distal to the proximal balloon weld.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 leak test.Based on the conducted investigations, no manufacturing or material relate root cause could be determined.The findings indicate that the balloon most likely burst due to application of pressure over rbp.The inner shaft including the balloon most likely fractured consequently during withdrawal due to tensile overload.

• Brand Name: PASSEO-35 XEO 8/40/90
• Common Device Name: 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: 17163902
• Report Number: 1028232-2023-03090
• Device Sequence Number: 5771792
• Product Code: LIT
• UDI-Device Identifier: 07640130451629
• UDI-Public: (01)07640130451629(17)2509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142379
• 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): 08/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2025
• Device Model Number: 428791
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09224549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown