MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS BARD SNARE RETRIEVAL KIT; PERCUTANEOUS RETRIEVAL DEVICE

Model Number	SRK35
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the snare retrieval procedure, an opening was allegedly found at the edge of the seal.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
This submission does not constitute a determination or admission that the device has malfunctioned or that the device was related to a death or injury.Complaint investigation results: according with the event description provided by the customer, the pictures and sample evaluation, and dhr review it can be concluded the reported event cannot be considered as a manufacturer related issue, based on the following facts: no deviations to established procedures or nonconformances related to the event description were identified in the record review.Evaluating the pictures and sample provided by the customer, it was found evidence that excess of forces, caused due to an inadequate handling, could damage the product, backer card and pouch surfaces.In-process controls are considered robust enough to detect similar damages during the packaging and sealing processes of the snare kit.This is the first event reported for similar issues.The process controls established in risk management documentation of similar failure modes, were reviewed and not deviations or nonconformances related to them were identified therefore, there is no evidence to confirm the issue is due to the manufacturing process.

• Brand Name: BARD SNARE RETRIEVAL KIT
• Common Device Name: PERCUTANEOUS RETRIEVAL DEVICE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 16822734
• Report Number: 3008988055-2023-00001
• Device Sequence Number: 17826492
• Product Code: MMX
• UDI-Device Identifier: 00857834006551
• UDI-Public: (01)00857834006551(17)240524(10)9007799412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: SRK35
• Device Catalogue Number: SRK35
• Device Lot Number: 9007799412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown