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

Model Number 3320

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/09/2023

Event Type  malfunction  

Event Description

It was reported that device leak occurred.A 1.25mm rotalink burr was selected for use.After unpacking, the physician connected the advancer before entering the patient's body.However, it was noted that the device was leaking liquid in the middle of the catheter, and so the physician decided to cut the device in order to save time.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.

Manufacturer Narrative

Returned product consisted of a portion of the rotalink burr atherectomy catheter coil.The burr housing and sheath were not returned for analysis.The handshake connection, sheath, burr, annulus, and coil were microscopically and visually examined.Inspection of the device found that the coil had been separated at 137cm from the burr.It was considered likely that this damage was attributable to the cutting of the device mentioned in the reported events.Functional testing of the device, including fluid infusion, was not able to be performed as the burr housing and sheath were not returned.Product analysis did not confirm the related complaint, as the device was not able to be functionally tested.However, review of the attached media was able to confirm the reported events.No other issues were identified during the product analysis.

Event Description

It was reported that device leak occurred.A 1.25mm rotalink burr was selected for use.After unpacking, the physician connected the advancer before entering the patient's body.However, it was noted that the device was leaking liquid in the middle of the catheter, and so the physician decided to cut the device in order to save time.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17851903
• MDR Text Key: 324696506
• Report Number: 2124215-2023-51349
• 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: 11/29/2023

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0030919262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG