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

Model Number	366133
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8540409
• Report Number: 1028232-2019-01553
• Device Sequence Number: 2443727
• Product Code: LIT
• UDI-Device Identifier: 07640130414754
• UDI-Public: 07640130414754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1