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

Model Number 3241

Device Problems Device Contamination with Chemical or Other Material (2944); Mechanical Jam (2983)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was noted that the device was contaminated.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink plus was selected for use.During the procedure, after rotation, it was noted that the guidewire could not cross the burr in vitro.It was checked and confirmed a foreign material was inside the device.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the annulus of the burr was damaged/not rounded.There was no foreign material identified within the device during analysis.Analysis was performed using a test rotawire, as the rotawire used in the procedure was not returned.The rotawire was not able to be inserted into the annulus due to the annulus no longer being round, restricting the wire.Product analysis confirmed the reported guidewire resistance, as the annulus was damaged/not rounded, preventing the rotawire from advancing into the device.The reported foreign material was not confirmed as no foreign material was identified within the device during analysis.

Event Description

It was noted that the device was contaminated.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink plus was selected for use.During the procedure, after rotation, it was noted that the guidewire could not cross the burr in vitro.It was checked and confirmed a foreign material was inside the device.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

• 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 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: 17424842
• MDR Text Key: 320047780
• Report Number: 2124215-2023-38915
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0029955112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 65 KG