MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-35 6/120/90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	383246
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 balloon was selected for treatment of a stenosis (80 percent stenosis degree) in a mildly tortuous distal fsa.After balloon deflation (even with negative pressure), it was difficult to pass through the sheath for withdrawal and afterwards for re-passing through the same sheath.
Additional Manufacturer Narrative
The returned product 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 balloon of the returned instrument has been inflated and was deflated in the as-returned state.A small amount of contrast medium residue was observed in the balloon- and inflation lumen.The balloon shows compression marks at the proximal end.Functional testing was performed by successfully inflating the balloon up to 7 atm (np), followed by balloon deflation.Under application of vacuum, the balloon could not be fully advanced through the returned introducer sheath, as the compressed part did not allow to pass the sheath, whereas a 6f fortress (45 cm) reference introducer sheath could be fully passed.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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PASSEO-35 6/120/90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 12333455
• Report Number: 1028232-2021-04628
• Device Sequence Number: 14631007
• Product Code: LIT
• UDI-Device Identifier: 07640130434288
• UDI-Public: 07640130434288
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082933
• 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): 08/16/2021

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: 08/31/2023
• Device Model Number: 383246
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08202981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1