MAUDE Adverse Event Report: COVIDIEN LP BARRX SHARKCORE; KIT, NEEDLE, BIOPSY

Model Number	DSC-22-01
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(patient underwent an x-ray to locate the needle tip inside the patient cavity).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an endoscopic ultrasound was performed for a submucosal mass of the stomach.Two passes were made with the device and as the third pass plunged into the mass, a crunching sound was heard.The device was removed from the patient and the team noticed that the shorter prong of the device mouth still appeared intact, but the larger tip appeared slightly fractured.An endoscopic ultrasound was used in an attempt to locate the tip without success.Staff checked the working channel of the scope and the sheath of the device, but no damage was detected.The patient experienced melena and was admitted to another hospital, and required two units of blood via transfusion.An x-ray of the kidney, ureter, and bladder (kub) done at outside facility; needle fragments were not identified.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received.The treating physician confirmed the patient did not need any additional blood transfusions and the patient is stable.
Additional Manufacturer Narrative
Evaluation summary one used dsc-22-01 was received for evaluation and investigated.The visual inspection found the tip of the needle was deformed, but the needle tip was still attached to the needle.A review of the device history record for the provided lot/serial number was completed and indicates all parameters and acceptance criteria for entries potentially pertinent to the reported event were within specified limits at the time of release.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHARKCORE
• Common Device Name: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 6515429
• Report Number: 3004904811-2017-05021
• Device Sequence Number: 1089072
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2017

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: 01/31/2019
• Device Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Device Lot Number: B000000234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: Not provided; 06/27/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/02/2017; 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention