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

Model Number	M001468080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, when the guidewire (subject device) was inserting into the microcatheter and was briefly advancing beyond the tip of the microcatheter to the right m2 branch; it was then withdrawn and used in the supraclinoid internal carotid artery (ica).When the physician tried to select the a1 origin, at this point it was noted that the tip (subject device) did not appear to be rotated in response to the movement of the torque device and the tip (subject device) was not engaged in a small vessel.No resistance was felt.The torque device was tightened and still no movement was seen.Another torque device was used, but the same issue occurred.It was realized that when withdrawing the wire (subject device), the tip (subject device) did not move and it was noted that the wire (subject device) was disconnected between the platinum tip and the remainder of the wire.Approximately half of the detached tip (subject device) was in the microcatheter.A snare was considered, but aspiration on the microcatheter with careful withdrawal with aspiration of all the remaining coaxial catheters (via 33, catalyst and neuromax catheter) allowed removal of the detached tip (subject device).There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date added.D9 product available to stryker updated.D9 returned to manufacturer on updated.H3 device evaluated by mfg updated.H3 summary attached updated.H4 manufacturing date added.The device history record (dhr) review that there is no indication that the device, labeling or packaging failed to meet its specifications when released.Analysis of the returned device revealed that the distal of the guidewire was broken/fractured and stretched.There was bending and kinking noted to the proximal section of the guidewire.As the torque device was not returned, a demonstration torque device was used for functional testing.The device was torqued with 1:1 movement.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 the device was prepared as per the dfu, no anomalies were noted prior to use, continuous flush was maintained, and no resistance was noted when advancing or retracting the guidewire through the microcatheter (headway duo).Since the headway microcatheter used in the procedure was not returned, it could not be determined whether interaction with the catheter may have contributed to the break.Based on the investigation, an assignable cause of procedural factors will be assigned to the reported event and analysed since these issues appear to be 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 that during procedure, when the guidewire (subject device) was inserting into the microcatheter and was briefly advancing beyond the tip of the microcatheter to the right m2 branch; it was then withdrawn and used in the supraclinoid internal carotid artery (ica).When the physician tried to select the a1 origin, at this point it was noted that the tip (subject device) did not appear to be rotated in response to the movement of the torque device and the tip (subject device) was not engaged in a small vessel.No resistance was felt.The torque device was tightened and still no movement was seen.Another torque device was used, but the same issue occurred.It was realized that when withdrawing the wire (subject device), the tip (subject device) did not move and it was noted that the wire (subject device) was disconnected between the platinum tip and the remainder of the wire.Approximately half of the detached tip (subject device) was in the microcatheter.A snare was considered, but aspiration on the microcatheter with careful withdrawal with aspiration of all the remaining coaxial catheters (via 33, catalyst and neuromax catheter) allowed removal of the detached tip (subject device).There were no reported clinical consequences to the patient due to this event.

• Brand Name: TRANSEND EX 14 PLATINUM 205CM
• 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: 10101997
• Report Number: 3008853977-2020-00016
• Device Sequence Number: 2654127
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K971254
• 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): 08/25/2020

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: 08/06/2021
• Device Model Number: M001468080
• Device Catalogue Number: M001468080
• Device Lot Number: 24231149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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: CATALYST 5 MICROCATHETER (STRYKER).; HEADWAY DUO CATHETER.; NEUROMAX CATHETER (PENUMBRA).; VIA 33 (UNKNOWN MANUFACTURER).