MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/170/150; PERIPHERAL DILATATION CATHETER

Model Number 366137

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

The passeo-18 balloon catheter was chosen for treatment of a severely calcified lesion (80 percent stenosis degree) in a moderately tortuous infrapopliteal artery.The balloon could not be inflated.

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 technical investigation revealed two small tears in the balloon surface, one located at the proximal end and one at the distal end of the distal radiopaque marker.Scratches were observed in close vicinity of both tears which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.The balloon is slightly unfolded but has not been inflated.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.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the patients anatomy (i.E.Severe calcification).

• Brand Name: PASSEO-18 2/170/150
• Type of Device: 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: 16936589
• MDR Text Key: 315269943
• Report Number: 1028232-2023-02455
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414792
• UDI-Public: (01)07640130414792(17)2503
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 366137
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03223255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1