MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Thrombosis (2100); Cardiogenic Shock (2262); Device Embedded In Tissue or Plaque (3165)

Event Date 07/04/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-06659.It was reported that the burr became detached and remained inside patient's body resulting in complications ultimately leading to patient death.The patient presented with heart failure, severe tritrunkular coronary artery disease and stenosis of supra-aortic trunks.The target lesion was located in the calcified and sub-occlusive stenosis of the circumflex artery.A 1.25 mm rotalink¿ burr and a 330 cm rotawire were selected for use.During preparation outside the patient's body during the speed test there was a failure of system to reach optimum speed despite a continuous flush.The rotalink advancer was changed to a new one and the same 1.25 mm rotalink¿ burr was connected and tested over the same 330 cm rotawire.The test passed therefore the burr was advanced into the patient for use.The burr advanced over the wire to the lesion without difficulties and treatment was initiated.On the sixth run (15 seconds at 150,000 revolutions/second), the burr including sheath broke (approximately 3 cm).The burr catheter and wire were removed from the patient, however the broken fragment remained in the circumflex artery causing an occlusion.Various attempts were made to remove the fragment but these proved to be unsuccessful.The patient went into cardiogenic shock, resulting in occlusion of the iva which was revascularized using angioplasty.Respiratory assistance was set up, as well as intra-aortic counterpulsation and catecholamine support.The patient eventually died during the procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was not returned for analysis, however media was received and reviewed by a member of bsc medical safety team.The results of the review are as follows: this media review demonstrated rotablator wire and burr shaft separation during a lcx-pci.Loss of flow in the lcx target vessel and severely diminished flow in the diseased lad followed the separation.The rotablator fragments were not retrieved as the burr appeared to be stuck in the lesion and the proximal fragment resting on the vessel wall.The patient experienced fatal circulatory collapse.Non-coaxial alignment of the guiding catheter with the lmt may have exacerbated angulation between the rotablator system and the target vessel.The additional angulation may have contributed to the rotalink shaft fracture which in turn severed the rotawire.Constraint of the burr by dense calcification may have contributed to the separation as well.Retrieval attempts were hindered by the fragment abutting the vessel wall thus not allowing the snare to capture the fragment.Slow flow in the entire lca distribution was associated with cardiogenic shock requiring mechanical hemodynamic, ventilatory and circulatory support.A dhr (device history record) review was performed and no deviation was found.Bsc id: (b)(4).

Event Description

Same case as mdr id: 2134265-2018-06659.It was reported that the burr became detached and remained inside patient's body resulting in complications ultimately leading to patient death.The patient presented with heart failure, severe tritrunkular coronary artery disease and stenosis of supra-aortic trunks.The target lesion was located in the calcified and sub-occlusive stenosis of the circumflex artery.A 1.25mm rotalink¿ burr and a 330cm rotawire were selected for use.During preparation outside the patient's body during the speed test there was a failure of system to reach optimum speed despite a continuous flush.The rotalink advancer was changed to a new one and the same 1.25mm rotalink¿ burr was connected and tested over the same 330cm rotawire.The test passed therefore the burr was advanced into the patient for use.The burr advanced over the wire to the lesion without difficulties and treatment was initiated.On the sixth run (15 seconds at 150,000 revolutions/second), the burr including sheath broke (approximately 3cm).The burr catheter and wire were removed from the patient, however the broken fragment remained in the circumflex artery causing an occlusion.Various attempts were made to remove the fragment but these proved to be unsuccessful.The patient went into cardiogenic shock, resulting in occlusion of the iva which was revascularized using angioplasty.Respiratory assistance was set up, as well as intra-aortic counterpulsation and catecholamine support.The patient eventually died during the procedure.

Event Description

It was reported that the burr became detached and remained inside patient's body resulting in complications ultimately leading to patient death.The patient presented with heart failure, severe tritrunkular coronary artery disease and stenosis of supra-aortic trunks.The target lesion was located in the calcified and sub-occlusive stenosis of the circumflex artery.A 1.25mm rotalink burr and a 330cm rotawire were selected for use.During preparation outside the patient's body during the speed test there was a failure of system to reach optimum speed despite a continuous flush.The rotalink advancer was changed to a new one and the same 1.25mm rotalink burr was connected and tested over the same 330cm rotawire.The test passed therefore the burr was advanced into the patient for use.The burr advanced over the wire to the lesion without difficulties and treatment was initiated.On the sixth run (15 seconds at 150,000 revolutions/second), the burr including sheath broke (approximately 3cm).The burr catheter and wire were removed from the patient, however the broken fragment remained in the circumflex artery causing an occlusion.Various attempts were made to remove the fragment but these proved to be unsuccessful.The patient went into cardiogenic shock, resulting in occlusion of the iva which was revascularized using angioplasty.Respiratory assistance was set up, as well as intra-aortic counterpulsation and catecholamine support.The patient eventually died during the procedure.It was further reported that the patient presented with alveolo-interstitial syndrome associated with right pleural effusion, elevation of nt-pro bnp and signs of left heart failure.Vascular access was obtained via radial approach.Bad hemodynamic tolerance with weak cardiac and cerebral flow was noted following the use of the burr catheter.The occlusion of the circumflex was thrombosis.An intra-aortic balloon pump and a central venous catheter were implanted.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; la aurora; maple grove MN 55311
• MDR Report Key: 7704384
• MDR Text Key: 114498808
• Report Number: 2134265-2018-06660
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0022134156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 09/18/2018; 08/14/2020
• Supplement Dates FDA Received: 09/21/2018; 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 65