MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, EMBOLECTOMY

Model Number IPN035902

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

During left upper arm fistula procedure, tip broke off terotola thrombectomy device.It was unable to be retrieved and was left in the patient.

• Brand Name: ARROW
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12432258
• MDR Text Key: 270167211
• Report Number: 12432258
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021,08/31/2021

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 Operator: Health Professional
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F21D0462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2021
• Date Report to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27375 DA