MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abscess (1690); Foreign Body In Patient (2687)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #k142688.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Needle tip broken into the patient, patient is today going well but after examination he did an abscess.They performed a scanner for confirmation and they could see needle tip around 1 cm into the lesion.Lesion was in the pancreas tail, very hard lesion.Dr made 2 pass and the needle broke at the second.As per completed customer complaint form: customer opened the sealed package without problem.They checked the device before to use, all seemed ok.They performed eus examination and decided to do punction.Lesion was in pancreas tail, and encho endoscope was not too much bending.They performed the first punction but lesion was very hard like a stone lesion, they get sample and decided to do second punction.Tip of the needle was a little bend but seemed not weakened.They performed the second punction and they removed the device from the scope they saw that tip of the needle was missing.They did a third punction with acquire needle and stop examination.At this moment they didn't know that tip of the needle was inside the patient.Some day later patient was painful and they did a scanner (crt) and they could see the tip of the needle into the lesion.Patient is still at the hospital, it is not painful for her but she probably should have a pancreas surgery for removing the lesion with the tip of the needle inside it.A quality defect report was received from the complaint facility on (b)(6) 2019 details of the incident: date of the incident: (b)(6) 2019: hepatic biopsy puncture under general anesthesia for a tumour at the top of the pancreas on the second stroke of the needle, the needle bent.Potential clinical consequences: patient returned on (b)(6) 2019 for abdominal pain with fever.The scan showed an abscess on the tumoral lesion at the bottom of the pancreas with a metal foreign body, likely a needle fragment.Occurred in unit digestive-system endoscopy the device in question has not been kept."incident information: date of occurrence: (b)(6) 2019.Description of the incident: (b)(6) 2019: liver biopsy punction for tumor of the head of the pancreas under general anesthesia.In the second passage of the needle, it is bent.(b)(6) 2019: patient returns for febrile abdominal pain.Ct scan shows abscess of tumor lesion of pancreatic tail with metallic foreign body probably corresponding to the needle piece.Patient information: current state of the patient: re-hospitalization (duration 15 days from (b)(6) 2019 to (b)(6) 2019) for febrile abdominal pain.Realization of a scanner highlighting a collection abscessed post-biopsy beginning in contact with the pancreatic lesion and containing within it a metallic foreign body.Antibiotic treatment and drainage of the abscess with removal of the foreign body.Actions undertaken in the facility: the needle piece could not be kept.".
Additional Manufacturer Narrative
Pma/510(k) #k142688.The echo-hd-3-20-c device of lot number c1579217 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Prior to distribution, all echo-hd-3-20-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (c1579217) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1579217.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to hard lesion, which may have caused the kink, which most likely led to the break.Complaint is confirmed based on the customers testimony and the image.According to the initial reporter, the patient did experience an adverse effect due to this occurrence.Pancreas abscess due to tip of needle in the lesion.The patient will require additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Needle tip broken into the patient, patient is today going well but after examination he did an abscess.They performed a scanner for confirmation and they could see needle tip around 1 cm into the lesion.Lesion was in the pancreas tail, very hard lesion.Dr made 2 pass and the needle broke at the second.As per completed customer complaint form: customer opened the sealed package without problem.They checked the device before to use, all seemed ok.They performed eus examination and decided to do punction.Lesion was in pancreas tail, and encho endoscope was not too much bending.They performed the first punction but lesion was very very hard like a stone lesion, they get sample and decided to do second punction.Tip of the needle was a a little bend but seemed not weakened.They performed the second punction and they they removed the device from the scope they saw that tip of the needle was missing.They did a third punction with acquire needle and stop examination.At this moment they didn't know that tip of the needle was inside the patient.Some day later patient was painful and they did a scanner (crt) and they could see the tip of the needle into the lesion.Patient is still at the hospital, it is not painful for her but she probably should have a pancreas surgery for removing the lesion with the tip of the needle inside it.A quality defect report was received from the complaint facility on 16-aug-19 details of the incident: date of the incident: (b)(6) 2019: hepatic biopsy puncture under general aneasthetic for a tumour at the top of the pancreas on the second stroke of the needle, the needle bent.Potential clinical consequences: patient returned on (b)(6) 2019 for abdominal pain with fever.The scan showed an abscess on the tumoral lesion at the bottom of the pancreas with a metal foreign body, likely a needle fragment.Occurred in unit digestive-system endoscopy the device in question has not been kept."incident information: date of occurrence: (b)(6) 2019.Description of the incident: (b)(6) 2019: liver biopsy punction for tumor of the head of the pancreas under general anesthesia.In the second passage of the needle, it is bent.(b)(6) 2019: patient returns for febrile abdominal pain.Ct scan shows abscess of tumor lesion of pancreatic tail with metallic foreign body probably corresponding to the needle piece.Patient information: current state of the patient: re-hospitalization (duration 15 days from (b)(6) 2019 to (b)(6) 2019) for febrile abdominal pain.Realization of a scanner highlighting a collection abscessed post-biopsy beginning in contact with the pancreatic lesion and containing within it a metallic foreign body.Antibiotic treatment and drainage of the abscess with removal of the foreign body.Actions undertaken in the facility: the needle piece could not be kept.".

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8954713
• Report Number: 3001845648-2019-00447
• Device Sequence Number: 11409308
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)220124(10)C1579217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2022
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C1579217
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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