MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 182CM; WIRE, GUIDE, CATHETER

Model Number	M001468050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned and the reported lot number was confirmed from the returned packaging.Visual analysis revealed that the guidewire was broken/ fractured at 42cm from the proximal end, with evidence of kinking and necking near the fracture point.The guidewire was kinked at 18cm from the distal tip.Functional analysis was unable to perform due to the condition of 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.No additional details of the reported event were provided.It is probable that there were difficulties experienced during advancing or retracting the device during the clinical procedure causing the damage noted to the device.An assignable cause of "procedural factors" will be assigned to this event as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu, but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
The subject guidewire was returned for analysis and it was discovered that the guidewire was broken/fractured inside the patient's anatomy during embolization procedure.No further information is available.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The reported complaint was confirmed based on analysis as it was found.The device failed to meet 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.Based on an additional information received, the subject guidewire was broken inside the patient¿s anatomy during procedure.The device was returned for analysis and the guidewire was noted to be broken/ fractured with evidence of kinking and necking near the fracture point.It is probable that there were difficulties experienced during advancing or retracting the device during the clinical procedure causing the damage noted to the device.An assignable cause of procedural factors will be assigned to the reported "guidewire broken/fractured during use"; and the analysed "guidewire broken/fractured inside patient" and "guidewire kinked/ bent", as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu, but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Additional information indicated that during the embolization procedure, after rinsing the subject guidewire, when retracting the micro-tip into the microcatheter, a rupture of the guidewire was observed between the micro-tip and its proximal attachment end.The procedure was completed successfully and there were no reported clinical consequences to the patient.

• Brand Name: TRANSEND EX 14 182CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CR 20101
• MDR Report Key: 9849841
• Report Number: 3008853977-2020-00009
• Device Sequence Number: 3308333
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K934122
• 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): 04/28/2020

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: 03/19/2021
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 23516141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: PROGREAT 2.7 MICROCATHETER(TERUMO)
• Patient Age: 69 YR