MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 10 205CM; WIRE, GUIDE, CATHETER

Catalog Number	M003468020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available for evaluation.
Event or Problem Description
It was reported during the percutaneous arteriovenous fistula embolization procedure when the physician was manipulating the subject guidewire, the tip of the device fractured.The subject guidewire and tip fragment was removed from the patient.The subject guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The guidewire was returned broken/fractured 189.5cm from the proximal end and was kinked/bent approx.186cm from the proximal end.The core wire was noted to be exposed at the fracture site.Functional testing was not performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was not tortuous, the guidewire tip was not shaped, the fracture occurred during manipulation, and all fractured pieces were removed from the patient.During analysis, the guidewire was noted to be broken/fractured at 189.5cm from the proximal end with the core wire exposed at the fracture site.The distal end of the wire was not returned.The guidewire was also noted to be kinked/bent at approximately 186cm from the proximal end.Based on the analysis, it is probable that the guidewire experienced torsion and/or tensile forces at the distal end possibly from manipulation against resistance which caused the device to kink and fracture.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire distal tip broken/fractured during use as well as the analyzed damage of the guidewire kinked/bent since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported during the percutaneous arteriovenous fistula embolization procedure when the physician was manipulating the subject guidewire, the tip of the device fractured.The subject guidewire and tip fragment was removed from the patient.The subject guidewire was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TRANSEND 10 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18499043
• Report Number: 3008853977-2024-00004
• Device Sequence Number: 7875921
• Product Code: DQX
• UDI-Device Identifier: 08714729201878
• UDI-Public: 08714729201878
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K964611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2024

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: 12/19/2024
• Device Catalogue Number: M003468020
• Device Lot Number: 30743046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: Asian