MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

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

Patient Problems Non specific EKG/ECG Changes (1817); Insufficient Information (4580)

Event Date 08/05/2023

Event Type  Injury  

Event Description

It was reported that the patient became unstable.The greater than 70% stenosed target lesion was located in the mildly calcified and moderately tortuous left circumflex artery.Following pre-dilation with a 3.00 x 12mm nc emerge, a 3.00 x 20mm agent dcb was advanced but was unable to cross the lesion.A 3.00 x 10mm wolverine cutting balloon was then used to prep the lesion.Following intravascular ultrasound, a 3.50 x 24mm synergy stent was successfully implanted.The physician then decided to move on to treat a lesion in the left anterior descending artery but was unable to cross with non-boston scientific small balloons.A 1.25 rotalink plus burr was introduced, but the patient was unstable while using the rotablator, procedure was stopped, and the lesion was alone for future interrogation.

Event Description

It was reported that the patient became unstable.The greater than 70% stenosed target lesion was located in the mildly calcified and moderately tortuous left circumflex artery.Following pre-dilation with a 3.00 x 12mm nc emerge, a 3.00 x 20mm agent dcb was advanced but was unable to cross the lesion.A 3.00 x 10mm wolverine cutting balloon was then used to prep the lesion.Following intravascular ultrasound, a 3.50 x 24mm synergy stent was successfully implanted.The physician then decided to move on to treat a lesion in the left anterior descending artery but was unable to cross with non-boston scientific small balloons.A 1.25 rotalink plus burr was introduced, but the patient was unstable while using the rotablator, procedure was stopped, and the lesion was alone for future interrogation.It was further reported that the patient was not unstable when they presented for the procedure and that when the patient became unstable, an intra-aortic balloon pump (iabp) was attached and an echocardiogram (echo) was performed.

Manufacturer Narrative

H6 impact codes: corrected.

Event Description

It was reported that the patient became unstable.The greater than 70% stenosed target lesion was located in the mildly calcified and moderately tortuous left circumflex artery.Following pre-dilation with a 3.00 x 12mm nc emerge, a 3.00 x 20mm agent dcb was advanced but was unable to cross the lesion.A 3.00 x 10mm wolverine cutting balloon was then used to prep the lesion.Following intravascular ultrasound, a 3.50 x 24mm synergy stent was successfully implanted.The physician then decided to move on to treat a lesion in the left anterior descending artery but was unable to cross with non-boston scientific small balloons.A 1.25 rotalink plus burr was introduced, but the patient was unstable while using the rotablator, procedure was stopped, and the lesion was alone for future interrogation.It was further reported that the patient was not unstable when they presented for the procedure and that when the patient became unstable, an intra-aortic balloon pump (iabp) was attached and an echocardiogram (echo) was performed.

Event Description

It was reported that the patient became unstable.The greater than 70% stenosed target lesion was located in the mildly calcified and moderately tortuous left circumflex artery.Following pre-dilation with a 3.00 x 12mm nc emerge, a 3.00 x 20mm agent dcb was advanced but was unable to cross the lesion.A 3.00 x 10mm wolverine cutting balloon was then used to prep the lesion.Following intravascular ultrasound, a 3.50 x 24mm synergy stent was successfully implanted.The physician then decided to move on to treat a lesion in the left anterior descending artery but was unable to cross with non-boston scientific small balloons.A 1.25 rotalink plus burr was introduced, but the patient was unstable while using the rotablator, procedure was stopped, and the lesion was alone for future interrogation.It was further reported that the patient was not unstable when they presented for the procedure and that when the patient became unstable, an intra-aortic balloon pump (iabp) was attached and an echocardiogram (echo) was performed.It was further reported that the patient's electrocardiogram (ecg) demonstrated st segment elevation.

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17720722
• MDR Text Key: 323089765
• Report Number: 2124215-2023-47572
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2023

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
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031377339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 09/27/2023; 11/28/2023
• Supplement Dates FDA Received: 09/27/2023; 09/27/2023; 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other