MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 4/150/130; PERIPHERAL DILATATION CATHETER

Model Number 366133

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

The technical investigation of the returned device revealed that the balloon shows no signs of inflation.The device hub was inspected and found to be liquid tight.An inflation device was connected and while applying pressure a fine jet of water was seen to emerge from the center of the balloon.Microscopic analysis showed a pinhole in the balloon center and scratches on the balloon surface nearby the damage site.Review of the production 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.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined.The final root cause for the reported event is most likely related to the patients anatomy.

Event Description

Ous mdr - as it was attempted to place the passeo-18 balloon catheter inside the lesion it was noticed that fluid was exiting from the hub.

• Brand Name: PASSEO-18 4/150/130
• 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: 8540409
• MDR Text Key: 142778136
• Report Number: 1028232-2019-01553
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 07640130414754
• UDI-Public: 07640130414754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 366133
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08183435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• 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