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

Model Number 3320

Device Problems Device Damaged by Another Device (2915); Output Problem (3005)

Patient Problems Chest Pain (1776); Hematoma (1884); Perforation (2001); Vasoconstriction (2126); Pericardial Effusion (3271)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that the wire fractured and the patient experienced a perforation, intramural hematoma and chest discomfort.The severely stenosed target lesion was located in the heavily calcified proximal-mid right coronary artery (rca).A 1.5mm rotalink burr, 2.00mm rotalink burr and a 330cm rotawire were selected for used.During the procedure, the burr was changed up to 2.00mm after ablation initially begun with a 1.5mm burr.During ablation, the 2.00mm burr stalled and the rotawire fractured.The fractured wire lodged into the posterior left ventricular (plv) and there was perforation and intramural hematoma in the rca.The wire was able to be removed.Two stents were deployed into the lesion which sealed the perforation.Ivus showed good seal, no significant effusion on bedside transthoracic echocardiogram (tte).Clinical decision was made to not proceed to stent the left anterior descending artery.Felodipine was commenced to reduce coronary spasm and the procedure was completed.Following the procedure, the patient endured mild constant chest discomfort, different from presenting angina.It was worse with deep inspiration and was consistent with inflammatory pericarditic etilogy.Troponin was 1417 post procedure in keeping with t4ami and tte showed left ventricular ejection fraction (lvef) of 40-45% representing trivial pericardial effusion.

Event Description

It was reported that the wire fractured and the patient experienced a perforation, intramural hematoma and chest discomfort.The severely stenosed target lesion was located in the heavily calcified proximal-mid right coronary artery (rca).A 1.5mm rotalink burr, 2.00mm rotalink burr and a 330cm rotawire were selected for used.During the procedure, the burr was changed up to 2.00mm after ablation initially begun with a 1.5mm burr.During ablation, the 2.00mm burr stalled and the rotawire fractured.The fractured wire lodged into the posterior left ventricular (plv) and there was perforation and intramural hematoma in the rca.The wire was able to be removed.Two stents were deployed into the lesion which sealed the perforation.Ivus showed good seal, no significant effusion on bedside transthoracic echocardiogram (tte).Clinical decision was made to not proceed to stent the left anterior descending artery.Felodipine was commenced to reduce coronary spasm and the procedure was completed.Following the procedure, the patient endured mild constant chest discomfort, different from presenting angina.It was worse with deep inspiration and was consistent with inflammatory pericarditic etilogy.Troponin was 1417 post procedure in keeping with t4ami and tte showed left ventricular ejection fraction (lvef) of 40-45% representing trivial pericardial effusion.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were microscopically examined.The coil has become stretched due to manipulation during the procedure.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 advancer that was used with this device during the procedure was returned for analysis and was confirmed to have a melted ultem.So functional testing was performed by connecting the rotalink burr device to a test rotalink advancer.The advancer was connected to the rotablator control console system.The rotablator system was able to reach optimum speed with no issues and the burr catheter spun/moved with no issues.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: ROTALINK BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10042838
• MDR Text Key: 190490449
• Report Number: 2134265-2020-06215
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• 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: 07/24/2020

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: 11/03/2020
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0023027275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention