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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pseudoaneurysm (2605); Vascular Dissection (3160)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported via journal article that plaque shift and multiple patient complications that required intervention occurred.A 7f 3.5 non-boston scientific (bsc) guide catheter with side holes was placed via the right femoral artery to the left coronary artery.Non-bsc guidewires were placed in the distal left circumflex artery (lcx) and distal left anterior descending artery (lad).Intravascular ultrasound (ivus) was used to check the lxc and lad sequentially for lumen size and plaque morphology evaluation.Ivus showed diffuse eccentric calcification along the lcx and extending from the ostial lcx to the left main (lm).The vessel size of the proximal lcx and proximal lad were 3.00/2.75mm.Rotational atherectomy was performed using a 1.75mm rota burr with a rota floppy wire along the proximal lcx to the lm up to 214,000rpm for 27 seconds.The angiogram showed timi 1 flow at the proximal lcx and plaque shift at the proximal lad.Hypotension and bradycardia developed.Norepinephrine and epinephrine administration started.The lcx was rechecked with ivus which showed intima disruption and asymmetric oval ostial lcx.Balloon angioplasty was performed with a 3.00mm semi compliant balloon along the proximal lcx to lm and two non-bsc drug eluting stents were deployed from the distal lcx to the lm using a non-bsc guide extension catheter.Proximal optimization technique (pot) at the lm was done with a 3.5mm balloon.Ivus showed good stent apposition but pseudoaneurysm.Another non-bsc stent was placed at the proximal lad to lm using a culotte technique.A non-bsc floppy wire was placed in the distal lcx.Intermittent hypotension and bradycardia developed during the lad intervention and an intra-aortic balloon pump (iabp) was placed via the left femoral artery.The lad was post-dilated using a 2.75mm balloon and kissing balloon technique using 3.00/2.75 balloons was performed at the lcx/lad.The vessels were rechecked using ivus which showed good stent apposition.Timi flow was 3 and the procedure was stopped.

Manufacturer Narrative

B3 date of event was estimated since the event date was not reported in the journal article.Shu yu tang, jen-kuang lee, "tctap c-007 catastrophic nightmare in an acs patient with calcified and torturous lm bifurcation lesion." journal of the american college of cardiology, vol.81, no.16, suppl s., 2023.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17050096
• MDR Text Key: 316472723
• Report Number: 2124215-2023-27948
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female