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

Model Number	3243
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Difficult to Remove (1528); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter city:(b)(6).
Event or Problem Description
It was reported that difficulty removing occurred.The 75 percent stenosed, 4mm-5mm diameter moderately tortuous and severely calcified target lesion was located in the right coronary artery (rca) proximal to right coronary artery (rca) distal with a length of 50mm.During set up, the rotation speed of the 2.25mm rotapro was set to 180,000 rpm and there was no problem noted.The burr was inserted into the guiding catheter in dynaglide mode; however the stall lamp lit up at the curve part on the proximal part of the guiding catheter tip.The hoses were rechecked and no kinks were noted.Another attempt was made to advance the burr using dynaglide but the stall lamp lit up.A squeaking sound was heard, so the guiding catheter was replaced.After replacement, the burr was inserted without problem.Ablation was performed from rca proximal to the distal of rca mid.A total of 4 ablations were performed.The rotation speed of the 1st and 2nd ablations were 170,000 rpm.The rotation speed of the 3rd and 4th ablations were 190,000 rpm.Duration of each ablation was 12 seconds.Ablation was completed.During removal, the burr became stuck at the calcification in the rca proximal and it was difficult to remove.Bailout was performed and the stuck burr was removed from the patient by cutting the shaft, taking out the drive shaft sheath and advancing the catheter along the drive shaft coil.After that, a 3.0 cutting balloon was applied and drug coated balloon (dcb) was performed.The procedure was successfully completed.The patient's status is good.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr: the coil, burr and annulus were microscopically and visually examined.The coil was cut 137cm from the distal tip of the burr.The rest of the device was not returned for analysis.Microscopic examination of the returned device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The coil is stretched.Inspection of the remainder of the device presented no other damage or irregularities.It was reported that the burr was inserted into the guiding catheter in dynaglide mode.The rotablator system dfu states: "gently push the burr through the guiding catheter to a point immediately proximal to the lesion.Never activate the burr while exiting the catheter.".
Event or Problem Description
It was reported that difficulty removing occurred.The 75 percent stenosed, 4mm-5mm diameter moderately tortuous and severely calcified target lesion was located in the right coronary artery (rca) proximal to right coronary artery (rca) distal with a length of 50mm.During set up, the rotation speed of the 2.25mm rotapro was set to 180,000 rpm and there was no problem noted.The burr was inserted into the guiding catheter in dynaglide mode; however the stall lamp lit up at the curve part on the proximal part of the guiding catheter tip.The hoses were rechecked and no kinks were noted.Another attempt was made to advance the burr using dynaglide but the stall lamp lit up.A squeaking sound was heard, so the guiding catheter was replaced.After replacement, the burr was inserted without problem.Ablation was performed from rca proximal to the distal of rca mid.A total of 4 ablations were performed.The rotation speed of the 1st and 2nd ablations were 170,000 rpm.The rotation speed of the 3rd and 4th ablations were 190,000 rpm.Duration of each ablation was 12 seconds.Ablation was completed.During removal, the burr became stuck at the calcification in the rca proximal and it was difficult to remove.Bailout was performed and the stuck burr was removed from the patient by cutting the shaft, taking out the drive shaft sheath and advancing the catheter along the drive shaft coil.After that, a 3.0 cutting balloon was applied and drug coated balloon (dcb) was performed.The procedure was successfully completed.The patient's status is good.

• Brand Name: ROTAPRO
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8449842
• Report Number: 2134265-2019-02674
• Device Sequence Number: 3013727
• Product Code: MCX
• UDI-Device Identifier: 08714729893400
• UDI-Public: 08714729893400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2020
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0022391739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 8F HYPERION; GUIDE CATHETER: 8F HYPERION; GUIDE CATHETER: 8F LAUNCHER JR4; GUIDE CATHETER: 8F LAUNCHER JR4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR