MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-18 5/200/90; PERIPHERAL DILATATION CATHETER

Model Number	376281
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A passeo-18 balloon catheter was chosen for treatment.The balloon was placed properly inside the lesion.As the balloon was inflated up to 6 bar the pressure of the balloon would slowly turn down.To keep the balloon inflated at 6 bar it was necessary to keep on giving more pressure.
Additional Manufacturer Narrative
28-sep-2021 pma number was incorrect on the original submission.Corrected to k151744.The returned instrument was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed a fine jet of water emerging from the center of the balloon when attempting inflation.Microscopic analysis of the balloon surface showed a small pinhole with transversal orientation about 62 mm proximal to the distal x-ray marker.At the origin of the pinhole scratches were observed which have likely been caused by a hard, sharp-edged object such as e.G.Anatomical structure.Review of the product release 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 and a pressure 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.
Additional Manufacturer Narrative
28-sep-2021: pma number was incorrect on the original submission.Corrected to k151744.

• Brand Name: PASSEO-18 5/200/90
• 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: 12540775
• Report Number: 1028232-2021-05344
• Device Sequence Number: 13780207
• Product Code: LIT
• UDI-Device Identifier: 07640130429888
• UDI-Public: 07640130429888
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151744
• 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,Followup
• Report Date (Section B): 09/27/2021

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: 01/31/2024
• Device Model Number: 376281
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01214725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 10/06/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 09/29/2021; 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1