MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIKING; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	87070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a perforation occurred.During a boston scientific defibrillator & lead implant procedure, the physician attempted to cannulate the coronary sinus with an acuity pro guide catheter and a viking electrode catheter.During the first attempt at cannulation, angiography showed contrast dye around the cardiac profile.The physician concluded the implant procedure, implanting a left ventricular lead.The patient was transferred to cardiosurgery where liquid dye and blood were drained to avoid pericardial tamponade.It was not possible to determine which device(s) had caused or contributed to the perforation; it was noted that "maybe both" had contributed.As of (b)(6) 2019, the patient was "fine" but remained hospitalized.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported a perforation occurred.During a boston scientific defibrillator & lead implant procedure, the physician attempted to cannulate the coronary sinus with an acuity pro guide catheter and a viking electrode catheter.During the first attempt at cannulation, angiography showed contrast dye around the cardiac profile.The physician concluded the implant procedure, implanting a left ventricular lead.The patient was transferred to cardiosurgery where liquid dye and blood were drained to avoid pericardial tamponade.It was not possible to determine which device(s) had caused or contributed to the perforation; it was noted that "maybe both" had contributed.As of (b)(6) 2019, the patient was "fine" but remained hospitalized.Additional information reported that the patient was discharged from the hospital with no further complications.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9570571
• Report Number: 2134265-2020-00057
• Device Sequence Number: 10872210
• Product Code: DRF
• UDI-Device Identifier: 08714729878049
• UDI-Public: 08714729878049
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 0023424365
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC ACUITY PRO GUIDE CATHETER; BOSTON SCIENTIFIC ACUITY PRO GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention