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

Model Number 3320

Device Problem Leak/Splash (1354)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that the device was leaking liquid.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure, it was noted that the advancer was leaking gas and sheath was leaking liquid.The procedure was completed with another of the same device.No patient complications and the patient status was stable.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

E2 - initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the sheath was damaged at the burr housing strain relief.Functional testing was performed with a test advancer.After the returned burr catheter was connected to the test advancer, the advancer was connected to the liquid infusion line.When liquid infusion was turned on, fluid leaked from the damaged portion of the sheath.

Event Description

It was reported that the device was leaking liquid.The target lesion was located in the left anterior descending artery.A 1.50mm rotalink burr was selected for use.During the procedure, it was noted that the advancer was leaking gas and sheath was leaking liquid.The procedure was completed with another of the same device.No patient complications and the patient status was stable.

• Brand Name: ROTALINK BURR
• 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: 18749575
• MDR Text Key: 336237720
• Report Number: 2124215-2024-09705
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185857
• UDI-Public: 08714729185857
• 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: 04/01/2024

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0029769226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG