MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. SUREFLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Lot Number	0034146490
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a sureflex bmc steerable sheath was selected for use.During the procedure, it was mentioned that a resistance was felt when removing the non-boston scientific orion catheter from the non-boston scientific sl1 (8.5fr).Afterwards, a resistance was considerably felt when removed after non-boston scientific orion was inserted and used into the sureflex sheath.When it was slowly pulled out, it was found that the tip of the orion shaft was bent.While outside the patient, the side port of sureflex was noted to be dislodged, so a new sureflex was used to continue the case.The non-boston scientific orion was not replaced.No patient complications were reported.The procedure was successfully completed.The device is expected to be returned for analysis.The side port fell out during removal of the non-boston scientific orion catheter and since this type of damage could lead to air ingress, the device was replaced immediately.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the sureflex steerable sheath was first visually inspected, and it failed; the stopcock valve tube came separately from the rest of the device.The visual inspection showed evidence of glue residue, that there was sufficient overlap between the sideport and the tubing, however no signs of cracks or tears in the tubing.There was minor damage noted to the ridge and both the minor and major (ridge) outside diameters.The pull test and leakage tests passed after re-installing the tubing onto the sideport.Later, the device showed no signs of leakage.An orion catheter was then inserted into the sheath, and while it was possible to fully insert and retract the catheter, past 16cm of catheter insertion some resistance was felt.Inserting past this point required incremental force, with the tip of the catheter appearing to have slight kink.The reported allegation is confirmed.Additionally, the field b5 (describe event or problem) was updated.
Event or Problem Description
It was reported that a sureflex bmc steerable sheath was selected for use.During the procedure, it was mentioned that a resistance was felt when removing the orion catheter from the non-boston scientific sl1 (8.5fr).Afterwards, a resistance was considerably felt when removed after orion was inserted and used into the sureflex sheath.When it was slowly pulled out, it was found that the tip of the orion shaft was bent.While outside the patient, the side port of sureflex was noted to be dislodged, so a new sureflex was used to continue the case.The orion was not replaced.No patient complications were reported.The procedure was successfully completed.The device is expected to be returned for analysis.The side port fell out during removal of the orion catheter and since this type of damage could lead to air ingress, the device was replaced immediately.

• Brand Name: SUREFLEX STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19877941
• Report Number: 2124215-2024-47471
• Device Sequence Number: 7778120
• Product Code: DYB
• UDI-Device Identifier: 00685447006213
• UDI-Public: 00685447006213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 07/20/2026
• Device Lot Number: 0034146490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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