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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Asystole (4442)

Event Date 07/01/2013

Event Type  Injury  

Event Description

It was reported via journal article that one patient reacted to rheolytic fragmentation with an episode of asystole.First-line treatment of high-risk pulmonary embolism with persistent hypotension and/or signs of shock is intravenous thrombolysis.However, if thrombolysis is contraindicated due to risk of serious bleeding, or if it yields insufficient effect, surgical thrombectomy or catheter-directed intervention (cdi) plus anticoagulation is recommended.The aim of this study was to assess the outcomes of the cdi modality introduced in a tertiary referral centre in 2013.Retrospective study of patients with high-risk pe treated by cdi followed by anticoagulation between july 2013 and december 2018.Rheolytic fragmentation was achieved using a 6f hydrodynamic catheter (angiojet ultra pe, boston scientific, marlborough, ma, usa).The cdi procedure in this institution includes various techniques depending on individual conditions for access to and distribution of emboli in the pulmonary circulation.Rheolytic fragmentation, using the angiojet system with a catheter approved for use in the pulmonary vessels, was applied in all but two patients, in whom the rotarex system was used.Severe side effects occurred in only 2 of 20 patients.One patient reacted to rheolytic fragmentation with an episode of asystole and another patient displayed repeated bouts of hypotension due to failing right heart performance.However, both conditions resolved spontaneously.

Manufacturer Narrative

Date of event estimated using first date in date range of retrospective study: 07/01/2013 through 12/31/2018.Initial reporter facility name: department of anaesthesiology and intensive care medicine, institute of clinical sciences, sahlgrenska academy, university of gothenburg and sahlgrenska university hospital.Einarsson, f., sandstrom, c., svennerholm, k., oras, j., & rylander, c.(2020).Outcomes of catheter-directed interventions in high-risk pulmonary embolism-a retrospective analysis.Acta anaesthesiologica scandinavica, 65(4), 499-506.Advance online publication.Https://doi.Org/10.1111/aas.13753.

• Brand Name: ANGIOJET
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15224356
• MDR Text Key: 297877414
• Report Number: 2134265-2022-08461
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other