MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guidewire was broken from the proximal end with core wire exposed and severely stretched with the platinum wire broken which suggests that excessive torque and manipulation during advancement of the guidewire resulted in the observed damage.The guidewire hydrophilic coating was checked with wet fingers.The coating was present on the guidewire but the surface was rough due to procedural fluids.The ptfe coating was inspected with wet fingers and no anomaly was noted.A functional test could not be performed as the guidewire was damaged and broken.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and the device was prepared for use as per the directions for use.The dispenser hoop was flushed before removing the guidewire, there was no resistance encountered removing the guidewire from the dispenser hoop and continuous flush was set up and maintained throughout the clinical procedure.There was friction/resistance encountered during the procedure and no force was used to overcome it but the guidewire was withdrawn.There were no other difficulties encountered during the usage of the device that could have contributed to the issue.The patient¿s anatomy was moderately tortuous.Other devices used in the procedure in conjunction with the subject device were guidewire, microcatheter and balloon catheter.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore an assignable cause of procedural factors will be assigned to the reported guidewire deformed, guidewire does not have smooth movement, guidewire distal tip stretched and the analyzed guidewire distal tip broken/fractured during use, guidewire distal tip stretched and guidewire hydrophilic coating surface rough.
Event or Problem Description
The subject guidewire was returned for analysis and the device investigation revealed that the distal tip of the subject guidewire was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• 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
• MDR Report Key: 12461413
• Report Number: 3008853977-2021-00034
• Device Sequence Number: 4815125
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022357
• 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
• Report Date (Section B): 09/13/2021

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: 06/03/2022
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 25561448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON10 MICROCATHETER (MEDTRONIC); GATEWAY BALLOON CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); UNKNOWN 6F GUIDE CATHETER