MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B7296, FORTE AXP SET 10/12/16F 45CM 6/BX; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	B7296
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Event description per customer experience report: "when the device was to be inserted over the guide wire, the sheath began to unwind in a spiral shape." additional information received via email 21oct2021 from [name], ametech regulatory affairs and quality assurance: photo of product attached.Patient status: no report of patient injury.
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Event description per customer experience report: "when the device was to be inserted over the guide wire, the sheath began to unwind in a spiral shape." additional information received via email 21oct2021 from [name], ametech regulatory affairs and quality assurance: photo of product attached.Additional information received via email (b)(6) 2021 from [name], ametech regulatory affairs and quality assurance: it is unknown what procedure was performed.It is unknown what other instrumentation was used in the procedure.The physician completed the case with another sheath from another manufacturer.The surgeon was not able to fix the spiral shape.If is unknown how the surgeon removed the sheath.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the sheath partially unraveling.Based on the condition of the returned unit, it is likely that the reported event was caused by a high force exerted on the unit.It is also possible that the sheath was more susceptible to unraveling.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: B7296, FORTE AXP SET 10/12/16F 45CM 6/BX
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12704477
• Report Number: 2027111-2021-00692
• Device Sequence Number: 4778229
• Product Code: FED
• UDI-Device Identifier: 00607915113551
• UDI-Public: (01)00607915113551(17)221021(30)01(10)1373130
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K993650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Expiration Date: 10/21/2022
• Device Model Number: B7296
• Device Catalogue Number: 100794803
• Device Lot Number: 1373130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2019
• 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