MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS

Model Number C315HIS02

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed.The analysis indicated that there was an issue with the catheter shaft.There was an issue with the septum of the catheter the septum of the catheter was damaged.Blood was observed on the septum of the delivery catheter.The analyst noted the delivery catheter was returned with the flush port capped and returned without the dilator.A 3830 test lead was inserted in the delivery catheter while flushing and was not able to pass through the catheter and stopped while trying to navigate through the bend in the distal end of the delivery catheter.The septum leaked at the damaged portion of the septum of the delivery catheter while flushing.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that five catheters from four different batches had a narrowing secondary curve, which resulted in a his lead getting stuck at the secondary curve.After the first catheter was attempted, the physician suspected that there was an issue with the his lead.They opened a second his lead and continued to have the issue of the lead getting stuck with the other three catheters.The four catheters and two his leads were removed and not used.A fifth catheter was inspected and determined to not have the narrowing defect.The fifth catheter was used successfully implant the third opened his lead.No patient complications have been reported as a result of this event.The catheter was returned to the manufacturer, analyzed, and tested out of specification.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12012684
• MDR Text Key: 256788622
• Report Number: 9612164-2021-02347
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00763000160180
• UDI-Public: 00763000160180
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010599479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR