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

Model Number	428791
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-35 xeo balloon catheter was selected for treatment of a moderately calcified lesion (50 percent stenosis degree) in the moderately tortuous proximal sfa.The passeo-35 xeo burst at a pressure of 9 atm.Since it was not possible to pull the balloon out through the sheath, it was removed all together.Nothing remained in patient.
Additional Manufacturer Narrative
01-mar-2024 updated description a passeo-35 xeo balloon catheter was selected for treatment of a moderately calcified lesion (50 percent stenosis degree) in the moderately tortuous proximal sfa.The passeo-35 xeo was positioned in the target lesion and inflated with 9 atm during which the balloon burst.Since it was not possible to pull the balloon out through the sheath, it was removed all together.Nothing remained in patient.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.In the as-returned state the affected device was located inside the 6f biotronik fortress 45 cm introducer sheath used in the intervention with about 55 mm of the device protruding from the distal end of the introducer sheath.In this state the balloon could not be withdrawn through the introducer sheath.It was thus pushed in distal direction which revealed that the balloon has burst longitudinally over a length of about 46 mm.Scratches were observed in close vicinity of the tear, indicating that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G., anatomical structure.After subsequent cleaning and rinsing the balloon could be withdrawn through the introducer sheath.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all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 of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The root cause for the reported event (i.E.Balloon burst) is most likely related to the patients anatomy.
Additional Manufacturer Narrative
(b)(6) 2024 updated description a passeo-35 xeo balloon catheter was selected for treatment of a moderately calcified lesion (50 percent stenosis degree) in the moderately tortuous proximal sfa.The passeo-35 xeo was positioned in the target lesion and inflated with 9 atm during which the balloon burst.Since it was not possible to pull the balloon out through the sheath, it was removed all together.Nothing remained in patient.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.In the as-returned state the affected device was located inside the 6f biotronik fortress 45 cm introducer sheath used in the intervention with about 55 mm of the device protruding from the distal end of the introducer sheath.The technical investigation confirmed that the balloon could not be withdrawn through the introducer.It was thus pushed in distal direction which revealed that the balloon has burst longitudinally over a length of about 46 mm.Scratches were observed in close vicinity of the tear, indicating that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the production documentation confirmed that the device 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 of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The root cause for the reported event (i.E.Balloon burst) is most likely related to the patients anatomy.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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.In the as-returned state the affected device was located inside the 6f biotronik fortress 45 cm introducer sheath used in the intervention with about 55 mm of the device protruding from the distal end of the introducer sheath.In this state the balloon could not be withdrawn through the introducer sheath.It was thus pushed in distal direction which revealed that the balloon has burst longitudinally over a length of about 46 mm.Scratches were observed in close vicinity of the tear, indicating that the damage of the balloon surface was caused by a hard, sharp-edged object such as e.G., anatomical structure.After subsequent cleaning and rinsing the balloon could be withdrawn through the introducer sheath.Review of the production documentation confirmed that the device 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 of the device being subject to this complaint, no manufacturing or material related root cause could be determined.The root cause for the reported event (i.E.Balloon burst) is most likely related to the patients anatomy.

• 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: 18658437
• Report Number: 1028232-2024-00686
• Device Sequence Number: 12587249
• Product Code: LIT
• UDI-Device Identifier: 07640130451629
• UDI-Public: (01)07640130451629(17)2605
• 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,Followup,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 428791
• Device Catalogue Number: 428791
• Device Lot Number: 04231792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 03/21/2024; 10/16/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/04/2024; 03/21/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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