MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 3/120/130; PERIPHERAL DILATATION CATHETER

Model Number	357508
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 balloon catheter was selected for use.After unpacking the doctor injected the balloon with heparinized saline to flush.Thereby it was noted that the lumen could not be flushed properly and a leakage was detected.
Additional Manufacturer Narrative
The returned device 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.During technical investigation of the returned device, an inflation device was attached to the connector and a leakage at the level of the luer hub was detected.As the issue was detected prior to use, no patient involvement was reported.The respective internal departments were informed to address the issue accordingly.

• Brand Name: PASSEO-18 3/120/130
• 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: 8866651
• Report Number: 1028232-2019-03244
• Device Sequence Number: 2824246
• Product Code: LIT
• UDI-Device Identifier: 07640119559193
• UDI-Public: 07640119559193
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 07/29/2019

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: 02/28/2022
• Device Model Number: 357508
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03190814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR