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

Model Number 3320

Device Problems Contamination (1120); Use of Device Problem (1670)

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

Event Date 04/23/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Event Description

It was reported that the device was contaminated.A 1.25mm rotalink burr was selected for percutaneous coronary treatment of the left anterior descending artery (lad).During preparation, after opening the package, the device fell from the sterile table to the floor and was therefore contaminated.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).H6: device codes: updated the device codes.

Event Description

It was reported that the device was contaminated.A 1.25mm rotalink burr was selected for percutaneous coronary treatment of the left anterior descending artery (lad).During preparation, after opening the package, the device fell from the sterile table to the floor and was therefore contaminated.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.It was further reported that device fell from the sterile table to the floor when the physician connected the machine.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17039604
• MDR Text Key: 316327535
• Report Number: 2124215-2023-27579
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: 08714729185864
• 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: 07/03/2023

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 Expiration Date: 05/31/2024
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0029690160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG