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

Catalog Number 5003

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  malfunction  

Event Description

6f catheter would not fit into recommended guide (6f) x'2.A 5f was opened pronto to finish procedure.Manufacturer response for pronto catheter 6f, pronto (per site reporter).Rep picked up product & sending in replacements.Manufacturer response for 6f pronto catheter, pronto (per site reporter).Sales rep picked up & sending in replacements.

• Brand Name: PRONTO
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9947991
• MDR Text Key: 187195735
• Report Number: 9947991
• 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: 02/13/2020,10/08/2019

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: No Information
• Device Catalogue Number: 5003
• Device Lot Number: 652171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1