MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2/170/150; PERIPHERAL DILATATION CATHETER

Model Number	366137
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-18 balloon catheter was selected for the treatment of a calcified lesion.After lesion crossing and positioning the passeo-18 balloon could not be inflated and a pinhole was suspected.
Additional Manufacturer Narrative
The returned instrument 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 that the device is well cleaned and the entire middle part of the balloon is missing.This is contrary to the pictures provided by the local staff in which the middle part balloon is still present.Due to the state of the device, presence of a balloon pinhole cannot be confirmed.Further investigation with regards to the reported complaint event is not possible.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 both a pressure and a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.Due to the state of the returned device a final root cause could not be established.

• Brand Name: PASSEO-18 2/170/150
• 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: 9158910
• Report Number: 1028232-2019-04352
• Device Sequence Number: 16606518
• Product Code: LIT
• UDI-Device Identifier: 07640130414792
• UDI-Public: 07640130414792
• 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): 10/04/2019

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: 07/31/2020
• Device Model Number: 366137
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07172045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1