MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 2.5/150/130; PERIPHERAL DILATATION CATHETER

Model Number	366130
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment of a mildly calcified lesion (80 percent stenosis degree) in a moderately tortuous posterior tibial artery.After inflation the balloon could not be removed.The balloon was stuck with the wire and the wire could not be remove from the balloon.Thus, the whole system (balloon with wire) were removed together from the sheath.
Additional Manufacturer Narrative
The returned instrument was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The instrument was returned with the guidewire used in the intervention.The guidewire is stuck in the guidewire lumen of the instrument and cannot be removed.The distal end of the guidewire is located about 60 mm distal to the proximal x-ray marker of the instrument.Microscopic inspection revealed a severe damage of the guidewire over a length of about 5 mm.In the damaged zone the coil of the guidewire has unwound which caused a blockage of the guidewire in the guidewire lumen of the instrument.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the damaged guidewire.

• Brand Name: PASSEO-18 2.5/150/130
• 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: 12099145
• Report Number: 1028232-2021-03694
• Device Sequence Number: 17208161
• Product Code: LIT
• UDI-Device Identifier: 07640130414723
• UDI-Public: 07640130414723
• 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): 06/30/2021

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: 11/17/2022
• Device Model Number: 366130
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02210130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1