MAUDE Adverse Event Report: MEDTRONIC VASCULAR TELESCOPE; CATHETER, PERCUTANEOUS

Model Number TELE6F

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

From staff: during an intervention of a right coronary artery a telescope (lot# 11587991) was used.While trying to insert a stent though the telescope the stent would not pass through the proximal portion of the telescope making it impossible to continue to use for the rest of the intervention.Per several staff members and the physician this has been a problem several times with telescopes since getting them back on the shelves.Manufacturer response for catheter, percutaneous, telescope (per site reporter) manufacturer has been made aware.[redacted name] (manufacturer rep) said there is a complaint file number is (b)(4).He is working on sending me a shipper kit so that i can send device back.

• Brand Name: TELESCOPE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 16853200
• MDR Text Key: 314379543
• Report Number: 16853200
• Device Sequence Number: 1
• Product Code: DQY
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TELE6F
• Device Catalogue Number: TELE6F
• Device Lot Number: 0011587991
• 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: 04/25/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 116 KG