MAUDE Adverse Event Report: INTEGER HOLDINGS CORPORATION BAYLIS MED TECH PASSPORT STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	PSS0705509
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.Integer is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by integer which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, integer, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, integer, or its employees, that the report constitutes an admission that the device, integer, or its employees caused or contributed to the event described in this report.
Event or Problem Description
There is a 60-minute procedure delay with this event.Deflection code added after the meeting with customer on 07apr2026.Customer organization: (b)(6).Event origin country: canada.Is product available to be returned for investigation? customer sent in rma1202123965, the 3 parts with blood.Complaint notified date to bmt: 31-mar-2026.Issue description: information received from customer via email on 31-mar-2026."today we had 3 7fr passport steerable sheaths that did not work.They kinked when we tried to flex them.I thought it was due to operator error however when you flexed the sheath as you are supposed to do it flexed into a twisted configuration making it unusable.Instead of 1 we had to use 4 and only when we used the 7fr 17 mm one did we actually have any useful function.I am not sure if this is a bad lot of sheaths, but this is unacceptable performance.It delayed the case by over an hour due to this problem.Dr.(b)(6) (surgeon)".Updated information on 2-apr-2026: "on the same day 3 other units of the same lot number seemed to be undamaged in packaging, but when they tried to deflect them, they were not deflecting properly ever so slightly bending in the shaft of the sheath.".

• Brand Name: BAYLIS MED TECH PASSPORT STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): INTEGER HOLDINGS CORPORATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): INTEGER HOLDINGS CORPORATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 24944758
• Report Number: 1035166-2026-00021
• Device Sequence Number: 12113984
• Product Code: DYB
• UDI-Device Identifier: 00885672012557
• UDI-Public: 00885672012557
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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 Model Number: PSS0705509
• Device Catalogue Number: PSS0705509
• Device Lot Number: S10049371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown