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

Model Number 3243

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that the burr detached inside the patient.The target lesion was located in the left anterior descending artery (lad).A 1.75mm rotapro was selected for use.The burr was placed in the park position after the second run.The burr detached inside the patient and a snare was used to retrieve the burr.The procedure was completed with another rotapro device.There were no patient complications reported.

Event Description

It was reported that the burr detached inside the patient.The target lesion was located in the left anterior descending artery (lad).A 1.75mm rotapro was selected for use.The burr was placed in the park position after the second run.The burr detached inside the patient and a snare was used to retrieve the burr.The procedure was completed with another rotapro device.There were no patient complications reported.It was further reported that the lesion was severely calcified.Calcification was estimated to be 70%-80%.

Manufacturer Narrative

Device analysis by mfr: the advancer, handshake connections, sheath, coil, burr and annulus were microscopically and visually examined.The device was returned intact, there was no separation on the device.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil has become stretched due to manipulation during the procedure.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10478238
• MDR Text Key: 205156288
• Report Number: 2134265-2020-12101
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893370
• UDI-Public: 08714729893370
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025220616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention