MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number	120602FP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a surgeon in the operating room had been using the fogarty catheter and the balloon had come off of the equipment.The physician was unable to retrieve this balloon.Patient demographics was requested but is unavailable.
Additional Manufacturer Narrative
The device was not returned for evaluation.Since the balloon was detached, the body of the catheter was discarded.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Additional information regarding patient health status has been requested.It is unknown if any additional procedure was required to retrieve the balloon.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Additional Manufacturer Narrative
The reported event of balloon being detached from the catheter was confirmed to be used in a endoscopic third ventriculostomy procedure.The patient is p.K.Dob (b)(6) 2019.The balloon was attempted to be retrieved by endoscopy, but was unsuccessful.Patient was discharged on (b)(6) 2021, but was later returned on (b)(6) 2021 for evd drain placement in er.He was admitted to the hospital and was diagnosis with hydrocephalus, port or reservoir infection, fever.Patient was then discharged on (b)(6) 2021 with a discharge diagnosis of hcp with surgical wound leak s/p vsp placement, meningitis.Representatives from the hospital state that there was no allegation of a correlation between the balloon detachment and subsequent patient hospitalization.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Additional Manufacturer Narrative
The reported event of balloon detachment was confirmed.The balloon was also found to be ruptured.Latex edges did not appear to match at the ruptured location.Per the ifu "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.No other visible damage or abnormality was observed from catheter body or windings.A personnel acknowledgment was provided to the manufacturing personnel.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12908865
• Report Number: 2015691-2021-06609
• Device Sequence Number: 4820395
• Product Code: DXE
• UDI-Device Identifier: 00690103205206
• UDI-Public: (01)00690103205206(17)231016(11)210717(10)63883761;(01)50690103205201(17)231016(11)210717(10)63883761
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/16/2023
• Device Model Number: 120602FP
• Device Catalogue Number: 120602FP
• Device Lot Number: 63883761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 01/11/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/23/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown