MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PASSEO-14 2.5/140/150; PERIPHERAL DILATATION CATHETER

Model Number	380339
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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).The device was delivered to the lesion but the balloon could not be inflated.The device was removed and another device was used to finish the intervention.
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.The instrument was returned with the balloon protector covering the balloon.The balloon is well folded and shows no signs of inflation.Functional testing was performed by inflating the balloon up to np.The balloon opened but water was observed leaking from the luer port of the guidewire lumen.Microscopic inspection revealed a small cut with a length of about 1 mm in the inner shaft inside the hub.The cut appears as if it was induced by 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 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.

• Brand Name: PASSEO-14 2.5/140/150
• 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: 11467157
• Report Number: 1028232-2021-01188
• Device Sequence Number: 3522887
• Product Code: LIT
• UDI-Device Identifier: 07640130433755
• UDI-Public: 07640130433755
• 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): 03/11/2021

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: 01/31/2023
• Device Model Number: 380339
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 12194131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1