MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Catalog Number CDSG-14-175

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customers "the wire guide in the colon decompression kit ¿split¿ and poked the finger of a tech." per complaint form: guide wire difficult to remove, as tech was pulling on wire it split and stuck him in the finger.

Event Description

As reported to customers "the wire guide in the colon decompression kit ¿split¿ and poked the finger of a tech." per complaint form: guide wire difficult to remove, as tech was pulling on wire it split and stuck him in the finger.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

**this is a final mdr report.The investigation was completed on 18-may-21.The results and conclusions are outlined in section h of this report.*** for all complaints, ask: 1.1.1 was the device flushed before use? yes.1.1.2 what was flushed through the device (water, saline, etc.)? na.1.1.3 was lubrication applied to the decompression tube? yes.1.1.4 details of the wire guide used (diameter, type, make)? 035 that comes in the kit.1.1.5 if not, with the device in question, how was the procedure finished? na.1.1.6 how experienced was the physician with using the cdsg? na.1.The file states that the device made patient contact.1a.Can you confirm if this is correct and the split wire guide was advanced into the patient? wire split when being removed from pt.Split end of wire was outside of pt.In hands of the tech.1b.Or did this occurred prior to use? 2.When was the split in the wire guide observed (prior to removal from packaging / during prep / during advancement etc.)? 3.How did the wire guide come to split? tech was pulling so hard on wire to remove it from the device it fragmented.4.Did the patient experience any adverse effects as a result of this event? no.5.Did the patient require any additional intervention? no.6.What was the outcome for the tech? was any intervention required in the case of the tech? tech was tested for infectious diseases and was cleared.

Manufacturer Narrative

510k# k171619.(b)(4) investigation: event description on (b)(6) 2019 cook was informed of a complaint on the wire component of a colon decompression set (cdsg-14-175, lot unknown).It was reported that the wire was difficult to remove from the holder, the tech had to use excessive force to remove it and in the process the wire broke and stuck the tech¿s finger.Subsequently, the tech was tested for infectious diseases and proven to be negative with no adverse effects.Device failure analysis: one torque wire guide (lot unknown) was returned used.The wire was twisted, kinked with the weld separated from the safety wire.The mandril and safety wire were protruding.The coils were elongated.The distal weld ball was missing.Device history record review: as the lot number was not provided, a review of device history record could not be performed.Device master record review: in response to this complaint (b)(4) reviewed the manufacturing instructions and quality controls relating to the reported failure mode.Mi_2703 rev 007 (d00189692) (various fixed wire guides) details the instructions for assembly and wire welding.The operator is instructed to: ¿4.4.9 cut only the mandril and safety wire so they are flush with the ¿a¿ end of the coil.The bend remains to hold adjustment in place until the guide is welded.4.4.10 trim excess safety wire from ¿b¿ end leaving approximately 4 cm of safety wire protruding from the coil (there should be no less than ½ cm protruding).4.4.11 verify flex length and overall length.¿ mi_1750 rev 022 (d00189625) ¿general manufacturing instructions for welders ¿.035"¿ includes the following: " 4.0 weld both ends unless otherwise stated.4.1.3.1 ensure mandril, coil, (and safety wire if applicable) are flush with the proximal end.4.1.8 lower and loosen twiste, and remove guide.Visually inspect weld.4.1.16 gently tug on coils to ensure both welds have captured coil, safety wire and/or the mandril.4.1.16.1 if the weld did not catch the mandril or safety wire, cut off the distal weld and, if needed, the proximal weld and repeat.4.1.17 visually inspect weld." qc_393 rev 004 (d00179858) ¿final inspection for torque guide¿ includes the following: ¿4.0 inspect all steps 100%, unless otherwise specified.Reference qsi03_05.4.5 verify surface of the guide is smooth, with no excessive tfe and tfe is not flaking or peeling, if applicable, and no offset or outstanding coils and weld and solder diameter.Guide should go through gauge with ease.4.6 verify distal and proximal end of the wire for secure weld and solders.Refer to specification.4.7 verify guide is relaxed properly at its distal tip.Refer to specification.4.7.1 verify some degree of slack is present between all solder joints as well as distal and proximal to soldered area.4.8 verify all solder placements and surface is not rough or sharp.Refer to specification.Visually examine, manually feel and measure with meter scale.4.9 verify flexibility at distal tip of guide.Refer to specification.4.10 verify that tapered mandril has a smooth transition and solders do not spin out while pulling over." (b)(4) has concluded that there are sufficient inspection activities in place to detect this failure prior to product distribution.Conclusion: the complaint was confirmed based on customer testimony as well as the analysis of the returned device.As the lot number was not provided the investigation into this issue was limited and a definitive cause could not be established.Cook has concluded that there are adequate inspection steps in place to capture this failure prior to distribution.With current information, possible causes such as manufacturing issues, handling damage or shipping/storage damage can not be ruled out.Cirl investigation completed by (b)(6) : the cdsg-14-175 device of unknown lot number was returned to cook ireland without the original packaging.With the information provided a physical and document based investigation was conducted.Mrb20-00014 was initiated for this complaint.The physical investigation was conducted at (b)(4) as they are the manufacturer of the device.For details of the lab evaluation findings, document review and root cause analysis please see the investigation conducted by (b)(4) above.According to the initial reporter the tech was tested for infectious disease and was cleared.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: COLON DECOMPRESSION SET
• Type of Device: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9415225
• MDR Text Key: 184851027
• Report Number: 3001845648-2019-00666
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• PMA/PMN Number: K900035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention