MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/60/130; PERIPHERAL DILATATION CATHETER

Model Number	357499
Medical Device Problem Codes	Material Puncture/Hole (1504); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned instrument 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 this event.The instrument was returned with the guidewire used in the intervention still stuck in the guidewire lumen which could be removed after proper flushing.The inner and the outer shaft are severely flattened over a length of 580 mm.The polymer coating of the guidewire has wrapped over at its proximal end, resulting in an outer diameter of 0.52 mm.The ifu and the product label specifies a maximum outer diameter of 0.46 mm for the guidewire.Further, the investigation revealed a fine jet of water emerging from the center of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole about 21 mm proximal to the distal x-ray marker.In close vicinity of the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G., anatomical structure.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.During final inspection a 100 percent control of the guidewire lumen viability is performed.All instruments successfully passed this test.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.We can therefore confirm that the instrument 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 pinhole is most likely related to the patients anatomy.The root cause for the reported friction issue is most likely related to the damaged competitors guidewire.
Event or Problem Description
A passeo-18 balloon catheter was selected for treatment of a severely calcified lesion (100 percent stenosis degree) in a segment of the distal sfa / p1 segment.By use of a 6f introducer sheath and a 0.018 inch guidewire the complaint instrument was advanced towards the target lesion, but neither the guidewire nor the complaint instrument was able to cross the target lesion.The balloon could then no longer be pushed over wire, like it was glued, and both devices could only be removed together.Further, in the cathlab report it is mentioned that the balloon of the complaint instrument burst during the first inflation.

• Brand Name: PASSEO-18 5/60/130
• 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: 17363924
• Report Number: 1028232-2023-03630
• Device Sequence Number: 20353491
• Product Code: LIT
• UDI-Device Identifier: 07640119559100
• UDI-Public: (01)07640119559100(17)2511
• 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
• Report Date (Section B): 07/20/2023

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: 11/23/2025
• Device Model Number: 357499
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11223117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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