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

Model Number	366137
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
A passeo 18 balloon catheter was chosen for the treatment of a severely calcified lesion in the arteriae tibialis anterior.The passeo 18 balloon was used to dilate the lesion.Although the pressure could not be maintained, it was tried several times, but the balloon still could not be filled during the expansion.
Additional Manufacturer Narrative
Combination product: yes 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 of the returned device revealed two tears with lengths and widths of up to 1 mm, which penetrates the balloon wall and reaches over a length of 2 mm beginning distal to the distal xray marker.It seems likely that the damage of the balloon surface was caused by a hard, sharp-edged object pressing against the balloon from the outside.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.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.The root cause is most likely related to the patients anatomy (i.E.Severely calcified target lesion).

• 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: 10960079
• Report Number: 1028232-2020-05329
• Device Sequence Number: 19630507
• Product Code: LIT
• UDI-Device Identifier: 07640130414792
• UDI-Public: 07640130414792
• Combination Product (Y/N): Y
• 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): 12/04/2020

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: 11/30/2022
• Device Model Number: 366137
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12190377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1