MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

Patient Problem Perforation of Vessels (2135)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

B3 date of event was estimated since the event date was not reported in the journal article.Chang, chiao h."tctap c-119 multiple complications in one case: how we handle it." journal of the american college of cardiology, vol.81, no.16, suppl s., 2023.

Event Description

It was reported via journal article that device entrapment and vessel damage occurred.Vascular access was obtained via the radial artery.A non-boston scientific (bsc) guidewire and 6f guide catheter were placed across the lesion.A low profile single marker compliant balloon was advanced using a non-bsc guide extension catheter but the lesion was not able to be dilated and rotational atherectomy was planned to prepare the lesion.It was first noted that the burr caused vessel injury and then that the floppy wire was broken.A balloon was immediately inflated at the injury site.There was no obvious tamponade and the patient vital signs were stable.The low profile balloon still failed to dilate the lesion so the puncture site was changed from the radial artery to femoral artery to increase system stability.Rotational atherectomy was again performed and was successful to manage.However, the 1.25 burr became entrapped and a catheter was used to remove the burr.The lesion was predilated using non-compliant balloons and stented with a drug eluting stent.An attempt was made to remove the broken wire using a multiple wire method but it failed so a snare was used to successfully remove the wire.An angiogram still showed proximal right coronary artery perforation so a covered stent was placed and no extravasation was found.

Event Description

It was reported via journal article that device entrapment and vessel damage occurred.Vascular access was obtained via the radial artery.A non-boston scientific (bsc) guidewire and 6f guide catheter were placed across the lesion.A low profile single marker compliant balloon was advanced using a non-bsc guide extension catheter but the lesion was not able to be dilated and rotational atherectomy was planned to prepare the lesion.It was first noted that the burr caused vessel injury and then that the floppy wire was broken.A balloon was immediately inflated at the injury site.There was no obvious tamponade and the patient vital signs were stable.The low profile balloon still failed to dilate the lesion so the puncture site was changed from the radial artery to femoral artery to increase system stability.Rotational atherectomy was again performed and was successful to manage.However, the 1.25 burr became entrapped and a catheter was used to remove the burr.The lesion was predilated using non-compliant balloons and stented with a drug eluting stent.An attempt was made to remove the broken wire using a multiple wire method but it failed so a snare was used to successfully remove the wire.An angiogram still showed proximal right coronary artery perforation so a covered stent was placed and no extravasation was found.

Manufacturer Narrative

B3 date of event was estimated since the event date was not reported in the journal article.Chang, chiao h."tctap c-119 multiple complications in one case: how we handle it." journal of the american college of cardiology, vol.81, no.16, suppl s., 2023.Correction, h6 device codes: updated to device damaged by another device.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17034994
• MDR Text Key: 316278264
• Report Number: 2124215-2023-27645
• 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,Followup
• Report Date: 06/16/2023

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?: Yes
• 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: 05/31/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/16/2023
• 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: 61 YR
• Patient Sex: Male