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

Model Number 3280

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

It was reported that a labeling issue occurred.A rotalink advancer was selected for percutaneous coronary intervention.However, during the procedure, it was noted that the device did not match the label.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

Manufacturer Narrative

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

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6) device evaluated by mfr: the complaint device was received for product analysis.The advancer body and handshake connection were visually examined.Inspection of the device presented no damage or irregularities.The batch number on the advancer was inspected and was found to be 30014220 in accordance with the reported batch number.Product analysis did not confirm the reported event, as there were no defects identified to the device, and the batch number on the device was found to match the batch number within the reported events.As additional packaging or other labeling content was not returned, the exact nature of the matching discrepancy was not able to be determined.

Event Description

It was reported that a labeling issue occurred.A rotalink advancer was selected for percutaneous coronary intervention.However, during the procedure, it was noted that the device did not match the label.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• Brand Name: ROTALINK ADVANCER
• 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: 17475040
• MDR Text Key: 320662641
• Report Number: 2124215-2023-40647
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0030014220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG