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

Model Number 3241

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 11/09/2014

Event Type  Injury  

Manufacturer Narrative

Case study source: muller, o.(2019, 04 02).Case study: entrapment of a rotablator in a freshly implanted stent surgically extracted.Retrieved from pcr online: https://www.Pcronline.Com/cases-resources-images/complications/implant-loss/coronary-embolised-devices/rotablator/case-library/case-study-entrapment-of-a-rotablator-in-a-freshly-implanted-stent-surgically-extracted.

Event Description

It was reported via case study that the device became entrapped in a stent.A 1.25mm rotablator and rotawire extra support wire were selected for use in a percutaneous coronary intervention (pci) of the mid right coronary artery (rca).Two days prior to the rotablator procedure, the mid rca was attempted to be ballooned and the distal rca was ballooned and stented.On the day of the rotablator procedure, the patient was noted to have chest pain recurrence and elevated hs-troponins.Rotablation was performed.During the second ablation, the device became stuck in the distal stent.The physician was unable to dislodge the device from the stent so both were surgically removed.It was concluded in this case study that the atherectomy should have been performed prior to implanting the stent and the culprit lesion was likely not treated.

• Brand Name: ROTALINK PLUS
• 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; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10391234
• MDR Text Key: 202386850
• Report Number: 2134265-2020-10878
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

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 Model Number: 3241
• Device Catalogue Number: 3241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/11/2020
• 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): Required Intervention
• Patient Age: 75 YR