MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366134
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted inflation of the passeo-18 balloon (complaint device) at site of lesion in sfa (80 percent stenosis degree).Upon starting inflation, no visible contrast was seen.Negative pressure was pulled on syringe and blood was withdrawn in line, indicating balloon rupture or hole.This balloon was withdrawn, and another passeo-18 with same lot (reported separately) was opened and reinserted.While attempting another inflation, the same incident happened.Balloon was withdrawn and replaced with like size competitive balloon.The competitive balloon inflated with no issue and procedure was completed.
Additional Manufacturer Narrative
The returned device was subjected to a 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 a fine jet of water emerging from the distal end of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole, 9 mm distal to the proximal 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 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 material or manufacturing related root cause was determined.The root cause for the reported event is most likely related to the patients anatomy.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference (b)(4).The returned device was subjected to a 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 a fine jet of water emerging from the distal end of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole, 9 mm distal to the proximal 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 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 material or manufacturing related root cause was determined.The root cause for the reported event is most likely related to the patients anatomy.

• Brand Name: PASSEO-18 5/150/130
• 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: 19360029
• Report Number: 1028232-2024-02771
• Device Sequence Number: 3797877
• Product Code: LIT
• UDI-Device Identifier: 07640130414761
• UDI-Public: (01)07640130414761(17)2701
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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 Model Number: 366134
• Device Catalogue Number: 366134
• Device Lot Number: 01240335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 11/05/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/02/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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