MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 6.0/60/90; PERIPHERAL DILATATION CATHETER

Model Number 357467

Device Problems Burst Container or Vessel (1074); Fracture (1260); Material Rupture (1546)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

Ous mdr - balloon and balloon catheter ruptured.This necessitate a surgical intervention.Further information is not available at this point in time.We are attempting to gather more information.The event date was not provided.The manufacturer has requested holding off on submitting patient and device codes until the technical investigation can be completed.

Manufacturer Narrative

The returned instrument 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 this event.The complaint device was returned in two parts.The balloon shows a transversal fracture in the center of the cylindrical balloon part.The inner shaft has ruptured proximal to the proximal x-ray marker and is severely elongated in the distal device fragment.The distal part of the balloon is compacted, indicating that this part of the balloon got caught on the distal end of the introducer sheath during the withdrawal attempt.Microscopic analysis of the balloon surface showed several scratches parallel to the fracture site on the proximal balloon fragment.No parts of the balloon are missing.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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.The conducted technical investigations and review of the production documentation did not reveal a material defect or manufacturing deviation.Due to the transversal scratch marks in close vicinity of the fracture site it is most probably that the rupture of the balloon was induced by the patient conditions.

• Brand Name: PASSEO-18 6.0/60/90
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6213870
• MDR Text Key: 63777036
• Report Number: 1028232-2016-05092
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 357467
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09162143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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