MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 XEO 5/200/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428917
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral balloon catheter was selected for dilatation of a severely calcified lesion in the mildly tortuous proximal to mid sfa.The device was flushed with saline at the straight port and the wire was inserted over the balloon tip.The passeo-35 xeo was positioned at the proximal sfa and inflated from np 9atm.The balloon was burst at 15atm inside the vessel and caused a minor dissection at the mid sfa.The device was then removed from patient.Half of the balloon body is detached from the system catheter.
Additional Manufacturer Narrative
The returned device 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 that the balloon has burst longitudinal over a length of about 62 mm.Scratches were observed along the edge of the burst which have likely been 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 product is tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the device was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the patients anatomy (i.E., calcified lesion).

• Brand Name: PASSEO-35 XEO 5/200/130
• 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: 19971553
• Report Number: 1028232-2024-04256
• Device Sequence Number: 21073401
• Product Code: LIT
• UDI-Device Identifier: 07640130452886
• UDI-Public: (01)07640130452886(17)2704
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K222065
• 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): 09/16/2024

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 Model Number: 428917
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03241452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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: Hospitalization
• Patient Sex: Unknown