MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34279
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During procedure needle tip kinked within the bronchoscope.As per complaint form: "dr.(b)(6), pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent.The needle couldn't be placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.
Additional Manufacturer Narrative
Pma/510(k) # k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Importer site establishment registration number: 3005580113.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.The echo-hd-22-ebus-p-c device of lot number c1580004 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 13-mar-19.A kink was identified at the notch of the needle.The needle was able to advance and retract with difficulty.Sheath extender was able to advance and retract.Prior to distribution, all echo-hd-22-ebus-p-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 (c1580004) 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 c1580004.The instructions for use, which accompanies this device, instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the user did not follow the ifu.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the patient anatomy as they mention that they experienced difficulty accessing the target site, and difficulty penetrating the target site.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿'non retraction of needle" during procedure needle tip kinked within the bronchioscope.As per complaint form: "dr.Semitzki-wess, pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent.The needle couldn't be placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿'non retraction of needle." during procedure needle tip kinked within the bronchoscope.As per complaint form: "dr.(b)(6), pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent.The needle couldn't be placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.
Additional Manufacturer Narrative
Pma/510(k) # k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿'non retraction of needle" during procedure needle tip kinked within the bronchioscope.As per complaint form: "(b)(6), pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent.The needle couldn't be placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8459643
• Report Number: 3001845648-2019-00128
• Device Sequence Number: 3013313
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)220128(10)C1580004
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 05/22/2019

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: 01/28/2022
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1580004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/26/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019; 03/04/2019; 03/04/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/24/2019; 05/22/2019; 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 62