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

Model Number	3320
Medical Device Problem Codes	Device Damaged by Another Device (2915); Output Problem (3005)
Health Effect - Clinical Codes	Chest Pain (1776); Hematoma (1884); Perforation (2001); Vasoconstriction (2126); Pericardial Effusion (3271)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10042838
• Report Number: 2134265-2020-06215
• Device Sequence Number: 3081846
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention