MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90; PERIPHERAL DILATATION CATHETER

Model Number	376281
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of a mildly calcified lesion (80 percent stenosis degree) in the popliteal artery.While inflating the balloon inside the patient, the patient moved his knee and the balloon ruptured.Upon removing, the balloon fractured in two parts.All parts were removed from patients body.
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 has a length of about 215 mm and the proximal fragment of about 821 mm.The balloon has burst in both transversal and longitudinal direction and has ruptured about 50 mm distal to the proximal balloon weld.The distal end of the balloon is crushed.Microscopic inspection revealed scratches on the balloon surface in close vicinity to the tearing edge.The inner shaft is elongated and constricted which implies application of a high tensile force.The inner shaft has fractured just distal to the proximal balloon weld.The inner shaft dimensions do not comply anymore with the specification.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 helium leak test.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The findings indicate that the balloon most likely burst due to anatomical/procedural factors.The instrument most likely fractured as a consequence during withdrawal due to tensile overload.

• Brand Name: PASSEO-18 5/200/90
• Common Device Name: PERIPHERAL DILATATION 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: 15469722
• Report Number: 1028232-2022-04896
• Device Sequence Number: 4688407
• Product Code: LIT
• UDI-Device Identifier: 07640130429888
• UDI-Public: (01)07640130429888(17)2503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072765
• 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): 09/20/2022

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: 03/31/2025
• Device Model Number: 376281
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03226864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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
• Patient Sex: Unknown