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

Model Number 29720

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that the burr would not advance or pull back on wire, lodged in calcified area and broke in half.The 90% stenosed target lesion was located in the severely tortuous and severely calcified vessel.A 1.25mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, the burr was used successfully until it did not go through a tight calcified lesion.Subsequently, the burr would not advance or pull back on wire and seemed to have lodged in calcified area; not advancing forward or on dyna glide.The catheter and wire were then pulled out together.After removal, the burr was removed intact but broke in half (due to calcification).The detached portion came out with catheter, and nothing was left behind.The procedure was completed and there were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the coil was kinked, stretched, and detached at 46cm from the handshake connection.Functional testing was initially performed using the returned rotawire.During testing, the returned rotawire was able to be removed with resistance but was not able to be reinserted due to the damaged coil.Further functional testing of the returned device was not able to be performed due to the damaged coil.Product analysis confirmed the reported detachment and stuck wire, as the coil was kinked, stretched, and detached, preventing insertion of the rotawire.The reported burr becoming stuck within the lesion was not able to be confirmed as clinical circumstances were not able to be replicated.

Event Description

It was reported that the burr would not advance or pull back on wire, lodged in calcified area and broke in half.The 90% stenosed target lesion was located in the severely tortuous and severely calcified vessel.A 1.25mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, the burr was used successfully until it did not go through a tight calcified lesion.Subsequently, the burr would not advance or pull back on wire and seemed to have lodged in calcified area; not advancing forward or on dyna glide.The catheter and wire were then pulled out together.After removal, the burr was removed intact but broke in half (due to calcification).The detached portion came out with catheter, and nothing was left behind.The procedure was completed and there were no patient complications reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 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: 18730411
• MDR Text Key: 336742334
• Report Number: 2124215-2024-07811
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729857808
• UDI-Public: 08714729857808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0032324139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1