MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY® REDDICK® CATHETER, W/13 GAUGE BY 8 IN NEEDLE INTRODUCER, 4 FR, 50 CM,

Model Number	E2400-52
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for evaluation.The investigation is ongoing.Once the investigation is complete, any additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Compliant alleges, "it (cath 1) was dirty from attempted use and the balloon did not inflate.The other one (cath 2) popped while in use and not from over-inflation.It may have had a defect in the balloon as well.Both are from batch #442310 both catheters are defective.Only 1 unique patient was involved.The patient was not harmed as a result.The procedure was not delayed.The devices were inspected before use but the inspection is not documented.Cath 1: a balloon inflation test was not performed prior to use as this changes the size of the balloon and it does not fit down the lumen of the catheter and is more likely to get torn intra-op once tested.Cath 2: the balloon ruptured during inflation.It was filled to the amount indicated on the syringe.It popped before removal.Sterile saline was used to inflate it.There were no visible signs of a defect prior to use.Once it popped it did not inflate again.".
Additional Manufacturer Narrative
Based on the internal investigation conducted in collaboration with the multidisciplinary team, it was determined that the non-conformity reported in this complaint could not be confirmed.The manufacturing process, applicable specifications, as well as dhr, were reviewed, and no anomalies were found.We can confirm that the parts are 100% inspected through functionality tests, which involve inflating the balloon and verifying that it meets the specifications.

• Brand Name: SYMMETRY® REDDICK® CATHETER, W/13 GAUGE BY 8 IN NEEDLE INTRODUCER, 4 FR, 50 CM,
• Common Device Name: CATHETER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: raghava bandi ; 3034 own dr; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22531647
• Report Number: 3007208013-2025-00034
• Device Sequence Number: 7410263
• Product Code: GBZ
• UDI-Device Identifier: 00841785113413
• UDI-Public: 00841785113413
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: E2400-52
• Device Lot Number: 442310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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