MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2/140/150; PERIPHERAL DILATATION CATHETER

Model Number	380338
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-14 balloon catheter was selected for treatment of a moderately calcified lesion (70 percent stenosis degree) in the moderately tortuous left subclavian artery.After lesion crossing it was not possible to inflate the passeo-14 balloon catheter.The device was removed and another balloon was used to finish the procedure.
Additional Manufacturer Narrative
The returned instrument 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 the reported event.In the as-returned condition the balloon of the complaint instrument is not well folded anymore and has clearly been inflated.An inflation device filled with water was attached to the luer port of the inflation lumen and pressure was applied.Water was found leaking from the luer port of the guidewire lumen.Inside the hub a less than 1 mm cut was detected in the inner shaft, indicating penetration with a sharp-edged object.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 pressure test and a helium leak test.All tested instruments passed these tests.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on these findings it seems likely that the root cause for the complaint event is related to external factors during the procedure or its preparations.

• Brand Name: PASSEO-14 2/140/150
• 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: 11957218
• Report Number: 1028232-2021-03207
• Device Sequence Number: 4403278
• Product Code: LIT
• UDI-Device Identifier: 07640130433748
• UDI-Public: 07640130433748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152240
• 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): 06/04/2021

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: 05/31/2023
• Device Model Number: 380338
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04204614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1