MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 FLOPPY 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468070
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when advancing the subject guidewire through the microcatheter, it was delaminated due to friction.The subject guidewire got stuck with catheter and it can not be advanced but can pull back.The procedure was completed and there were no reported clinical consequences to the patient.No other information was provided.
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual and microscopic examination of the returned subject guidewire device found that the subject guidewire was noted to be heavily kinked/bent and the subject guidewire was returned stuck in the sl-10 microcatheter.The devices were soaked in warm water, the subject guidewire could not be removed from the microcatheter, the subject guidewire was damaged further during analysis.A functional inspection could not be performed as the subject guidewire remained stuck in the sl-10 microcatheter.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.Analysis of the returned device found the transend guidewire stuck in the sl-10 microcatheter used in the procedure and could not be removed.The guidewire was significantly kinked which suggests that excessive torque and manipulation during advancement of the guidewire in the sl-10 microcatheter resulted in the observed damage.The reported 'guidewire delamination¿ could not be determined during analysis as the guidewire remained stuck in the sl-10 microcatheter.Therefore an assignable cause of ¿undeterminable-root cause could not be determined¿ to the reported 'guidewire delamination¿ as review and analysis of all available information fails to indicate and assignable cause or probable assignable cause.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 'nv - guidewire difficult to advance¿, ' guidewire friction¿ and analyzed ¿guidewire difficult to advance¿, ¿guidewire friction¿ and ¿guidewire kinked/bent¿ were confirmed during analysis.
Event or Problem Description
It was reported that when advancing the subject guidewire through the microcatheter, it was delaminated due to friction.The subject guidewire got stuck with catheter and it can not be advanced but can pull back.The procedure was completed and there were no reported clinical consequences to the patient.No other information was provided.

• Brand Name: TRANSEND EX 14 FLOPPY 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: 13154824
• Report Number: 3008853977-2022-00002
• Device Sequence Number: 20170418
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K944677
• 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): 05/09/2022

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: 08/10/2023
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 27813236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown